Abstract:
A collapsible personnel isolation apparatus for preventing unwanted contaminations of hazardous biological and chemical materials including a base. A cover connects to the base by way of a zipper. A plurality of glove box ports are provided to allow rapid and convenient treatment of the patient.

Description:
CROSS REFERENCE TO RELATED APPLICATION  
       [0001]    Priority is claimed from U.S. provisional application no. 60/113,503, filed Dec. 21, 1998. 
     
    
     GOVERNMENTAL RIGHTS  
       [0002] The subject matter disclosed and claimed herein was developed under Department of Defense Contract No. DLA900-93-D-0011/0038. The government has certain rights in the invention. 
     
    
     
       BACKGROUND OF THE INVENTION  
         [0003]    The invention relates to isolation pods and particularly to a collapsible low cost pod for isolating a person previously exposed to a chemical or biological hazard from a safe environment, or in the alternative, for isolating an unexposed person from a hazardous environment for medical transport.  
           [0004]    The threat to health from biological and chemical contaminants has, if anything, increased over the last several years. The popular press is full of accounts of potential biological attacks which might either be privately or state sponsored. Chemical terrorist attacks have already occurred in various areas of the world and certain governments have engaged in chemical attacks against enemies and even members of their own society. While the risks from chemical attacks are believed to be substantial, in the future the threat of biological attack may continue to increase and may become more significant than chemical attacks.  
           [0005]    Apparatus are currently available for transporting victims of natural biological hazards. Such victims may include persons who have been infected with Ebola or Marburg virus, anthrax or the like. One such system is the so-called Vickers box which comprises a relatively self-contained unit having an external frame with a biological hazard barrier comprising sheet polyvinyl chloride sheet suspended therefrom. The frame has a foot rest or step. A lower substantially oval loading port provides access to the interior through which a patient may be carried to rest on a stretcher-like structure. The barrier has a ventilation tube entering its foot end. Glove ports are formed on the sides of the frame thereof. A pass-through port extends through the barrier near where the calves of a patient would normally rest. There are pairs of glove ports on each side of the unit. Intravenous bags and the like may be suspended from the frame of the unit. An intravenous line may extend through a port in the side of the unit. The Vickers box weighs over 200 pounds unloaded. In addition, the Vickers box is not disposable and is very expensive. It typically costs $20,000 to $30,000. When assembled the Vickers frames are bulky and the unit is simply not adapted for storage in large numbers for use in the event of a biological emergency. In addition it cannot be transported in all types of military evac vehicles.  
           [0006]    Another approach has been taken in U.S. Pat. No. 5,626,151 to Linden. Linden discloses a transportable life support system including a base  2 , a stretcher  3 , and a rigid cover  4 . The base may be constructed from a fiber reinforced resin composite. Medical equipment is housed within the base including a ventilator  11 , an oxygen source  12  such as an oxygen tank or oxygen generator, a suction unit  13  and an environmental control unit  14 . A high volume intravenous pump  23 , a pulse oximetry sensor  24  a blood pressure sensor  25  and electrocardiography sensor all are relatively bulky and may or may not be needed for the treatment for the particular patient depending upon whether the patient had merely been exposed or has been infected. The environmental control unit includes means for providing contaminant-free air to the unit including at least one filter  14 B, which may be a typical nuclear-biological-chemical type filter. The problem with such a unit is that it appears to be relatively bulky because of the built-in components in the base of the unit and the unit may not quickly and easily be stored in a compact configuration and may represent overkill for a variety of hazards.  
           [0007]    What is needed then is an inexpensive easily transportable compact biological isolation system for use in isolating victims in a chemical or bioterror event.  
         SUMMARY OF THE INVENTION  
         [0008]    A collapsible personnel isolation apparatus for isolating an individual who may have been exposed or has been infected with a biological agent or may have been exposed with a chemical agent embodies the present invention and is particularly well adapted for compact storage. The collapsible personnel isolation system embodying the present invention may include a pod, a suit or a flexible wrap. The system is inexpensive, may be completely disposed by burning or the like, and provides facilities for a variety of medical interventions without the necessity that expensive treatment equipment be associated therewith.  
           [0009]    The system includes a flexible base, which may be made from polyvinyl chloride material and which is tear resistant. Specifically the base includes an outer sheet and an inner sheet. Each of the inner and outer sheets has first and second polyvinyl chloride outer layers with an intermediate nylon mesh layer positioned between. A nylon webbing formed in the shape of a ladder includes a pair of upright or runner elements extending longitudinally on opposite sides of the base for providing support when the base is carried. The nylon webbing is positioned between the inner and outer sheets. This prevents the base from tearing and provides support to handholds in the base. Lateral or central spine type support is provided by five nylon web strips connecting the two longitudinal strips.  
           [0010]    Rectangular handholds are formed adjacent to the elongated nylon uprights for grasping by persons carrying the patient. If the patient is being carried by stretcher, grommets formed in the walls of the sheets accept hooks, cords or other tension members. The tension members wrap the base material around a stretcher, in particular a decontamination stretcher, for transport of the patient.  
           [0011]    A clear 20 mil thick PVC material extends upwardly from the base into an over area and terminates at each side at a zipper half. The zipper halves are completely separable so that the apparatus may be opened in a clamshell arrangement and a patient may be laid therein. This is particularly important with patients infected by hemorrhagic fevers such as Ebola or Marburg. Such patients may resist handling. Attempts to place the patient into a prior art isolation system, such as a Vickers box, where there is a relatively small port of entry can be difficult without contaminating the handlers. It may be appreciated that contamination of the environment and other persons must be avoided in order to prevent the spread of these types of virulent viruses.  
           [0012]    Accordingly, the present invention, as embodied in the apparatus, is easily closed around the patient without panicking the patient and without unwarranted spread of virus during the process.  
           [0013]    The PVC material has a plurality of flexible, nylon ribs or stays positioned in sleeves to provide support. The stays are used to hold the transparent PVC shell away from the patient to allow the patient to be manipulated and to reduce the patient&#39;s sense of from being enclosed within the pod. Multiple pairs of glove box ports are provided in the sides of the walls of the unit and at the head end to allow physicians, nurses or other medical professionals to treat the patient within the apparatus without exposing themselves to the infected patient.  
           [0014]    A pass-through port is provided for transferring materials in a one way fashion from the outside to the interior of the pod without exposing others. A plurality of small outwardly extending access ports are provided through which may be extended electrocardiographic leads, a suction pump line, infusion lines from a intravenous infusion pump or the like. A larger port is provided for extending a ventilator tube from the outside to a patient to provide ventilation through an airway extending into the patient&#39;s trachea. A single glove box port is positioned at the head end of the apparatus to allow a physician or other care giver to intubate the patient.  
           [0015]    A plurality of internal storage pouches are provided within the apparatus. The pouches may be preloaded with a variety of supplies such as first aid or medical kits including gauze, tape, various antibiotics, analgesics and the like. The supplies are made available for rapid administration to a patient, particularly a patient who might be in extremis. A pair of patient straps are provided which extend from side to side on the interior of the base to anchor the patient with respect to the base of the pod. While not intended to restrain the patient, they help to maintain the base of the apparatus in contact with the patient so that the upper clear walls of the apparatus are spaced away from the patient and not in contact with him or her.  
           [0016]    A blower and filter are provided which may be connected either to the head end or the foot end of the pod. The blower may provide positive pressure to the pod in the event that the patient is uncontaminated and the immediate environment around the patient is contaminated. That is relatively clear air from within the pod would be exhausted to a hot environment. The blower also may be connected to the opposite and of the pod and run in the other direction to provide negative pressure within the pod which is the more usual configuration. This configuration is used when the patient is hot or contaminated and the environment is relatively or completely uncontaminated. This prevents the release of contaminants including pathogens to the environment. Air is drawn in through one of the ports and is exhausted through a filter system at the blower which prevents the pathogens from being released into the environment. The blower, however, when operated in either mode, provides air to the patient so that the patient may breath. The blower may be energized by lithium batteries or D-cell batteries and may have a life for one set of batteries of up to fifteen hours of service time. This is enough time to transport the patient from a casualty site to a hot handling facility.  
           [0017]    A drain port is also provided at the foot end of the pod in an end wall thereof. Any liquid which may be present or form within the apparatus due to decontamination or release of contaminated fluids from the patient may be drained out of the apparatus while the patient is isolated inside. Such patient-generated fluids would likely be biologically contaminated. Fluid removal is done simply by elevating the head end of the pod with respect to the foot end and allowing the fluid to travel out by gravity. A patient for instance who might be contaminated with a biological contaminant can be decontaminated within the pod with a rinse such as water or some other liquid decontaminant which may comprise a decontaminant solution.  
           [0018]    The blower and filter assembly may be optionally supported by a stand having a sleeve-type clamp. The clamp may be attached to a handle of a decontamination stretcher for convenient support. It allows anchoring the blower and filter assembly substantially fixed with respect to an air inlet at the head end of the apparatus adjacent the head of the patient when the apparatus is to be operated in positive pressure mode. The blower and filter may also be similarly mounted at the front end of the stretcher for operation of the apparatus in the negative pressure mode.  
           [0019]    It may also be appreciated that coverings are provided for the port holes for each of the glove box arms so that any glove box arms remaining sealed need not later be decontaminated.  
           [0020]    A number of the ports connected to the walls include flexible diaphragms which are opened when connected to the blower and filter assembly and closed when unconnected to maintain isolation between the interior of the apparatus and the surrounding environment.  
           [0021]    It is a principal aspect of the invention to provide a portable, inexpensive and easily stored isolation system for isolating a patient from an environment for preventing the transport biological and chemical agents between the environment and the person.  
           [0022]    Other aspects and advantages of this invention will become apparent to one of ordinary skill in the art upon a perusal of the following specification and claims in like of the accompanying drawings. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0023]    [0023]FIG. 1 is a perspective view of an isolation apparatus, specifically an isolation pod, embodying the present invention, having plastic tube stays, having a person lying therein, and being supported by a mobile intensive care rescue facility;  
         [0024]    [0024]FIG. 2 is a perspective view of the isolation apparatus shown in FIG. 1 but having nylon rod stays and being mounted upon a decontamination stretcher;  
         [0025]    [0025]FIG. 3 is a perspective view of the opposite side of the isolation pod shown in FIG. 2 showing details of a zipper closure and a ventilation system.  
         [0026]    [0026]FIG. 4 is an end perspective view of the isolation pod shown in FIG. 2 showing details of the region in which a patient&#39;s feet would rest and showing details of a portion of a glove box assembly;  
         [0027]    [0027]FIG. 5 is a further view of the glove box assembly shown in FIG. 4;  
         [0028]    [0028]FIG. 6 is a partial perspective view of a portion of the isolation pod shown in FIG. 2 showing details of its attachment to the decontamination stretcher;  
         [0029]    [0029]FIG. 7 is a partial perspective view of the isolation pod shown in FIG. 2 showing a pair of clamped-off ports extending from a lower portion thereof and showing details of a handhold;  
         [0030]    [0030]FIG. 8 is a partial perspective view of the isolation pod shown in FIG. 2 and showing a zipper-type sealed opening for a glove arm for manipulation of a patient or instruments within the isolation pod;  
         [0031]    [0031]FIG. 9 is a partial perspective view of the isolation pod shown in FIG. 2 showing a transfer port together with a glove port arm;  
         [0032]    [0032]FIG. 10 is a partial perspective view of the isolation pod shown in FIG. 2 showing details of multiple glove pairs therein and multiple access ports;  
         [0033]    [0033]FIG. 11 is partial perspective view of the isolation pod shown in FIG. 2 showing the transfer assembly together with one of the glove box assemblies;  
         [0034]    [0034]FIG. 12 is a partial side view of the isolation pod shown in FIG. 2 showing the relation between the zippers, the ports and the gloves of the glove box;  
         [0035]    [0035]FIG. 13 is a partial perspective view of the isolation pod shown in FIG. 2 showing a ventilation system and its attachment in ventilating communication to an upper portion of the isolation pod;  
         [0036]    [0036]FIG. 14 is an end perspective view of the isolation pod shown in FIG. 2 showing a head end of isolation pod having a single port for use in manually intubating a patient within the isolation pod;  
         [0037]    [0037]FIG. 15 is a perspective view of the isolation pod shown in FIG. 2 in an open configuration;  
         [0038]    [0038]FIG. 16 is another perspective view of the isolation pod shown in FIG. 2 shown in the open configuration;  
         [0039]    FIGS.  17 - 19  are perspective views of an alternative embodiment of the isolation pod having a centerline zipper closure; and  
         [0040]    [0040]FIG. 20 is a perspective view of still another alternative embodiment of the isolation apparatus, showing an isolation pod having a centerline zipper partially open. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0041]    Referring now to the drawings and especially to FIGS. 1 and 2, a collapsible personnel isolation apparatus embodying the present invention is shown therein and generally identified by reference numeral  10 . The collapsible isolation apparatus  10  is an isolation pod and includes a flexible base  12  and a transparent cover  14 . The transparent cover comprises a transparent flexible polyvinyl chloride wall having a thickness of 20 mils or 0.020 inch. The transparent cover  14  has a plurality of internal supports or stays  16 . The stays may be plastic tubes, as shown in FIG. 1 or nylon rods, as shown in FIG. 2. The stays  16  extend through portions of the cover  14  and support it with respect to the base  12  to prevent the cover  14  from collapsing onto a patient who may be placed therein. A closure  20  comprising a zipper extends partially along a back wall  22 , completely along a pair of side walls  24  and  26  and a front wall  28 . The zipper  20  is a 132-134 inches long gas seal zipper and may be obtained from YKK of Japan. The zipper  20  holds the pod closed and causes the stays to be compressionally curved into arches to support the wall  14 . It also provides a clamshell opening configuration defining a bottom  30  and a top  32 . The bottom  30  includes the base  12  and a portion of the transparent cover  14 . The top  32  includes the remainder of the transparent enclosure  14 . The pod  10  is collapsible into a very small volume and may be stored in a duffle bag. It may be rapidly deployed and is self-supporting.  
         [0042]    The clamshell opening configuration allows a patient to be easily placed within the interior of the pod  10  type apparatus providing secure isolation of the patient from the environment and vice-versa. In order to prevent the patient from damaging the pod  10  after having been enclosed therein by enclosing the bottom  30  to the top  32  by way of the zipper a pair of anchoring belts  40  and  42  are provided and are attached to the base. Belt  40  includes a first half  44  and a second half  46 . The belt  42  includes a first half  48  and a second half  50 , as shown in FIGS. 15 and 16. In addition, the base  12  is provided with a capped drain  54  from which fluids may be drained from the interior of the pod  10  such fluids may be decontamination fluids or fluid materials generated by the patient themself.  
         [0043]    The material of the flexible base is constructed of an outer sheet and an inner sheet. Each of the sheets has first and second polyvinyl chloride outer bags with an intermdant nylon mesh layer. A nylon webbing formed in the shape of a ladder includes a pair of uprights or runner elements extending longitudinally on opposite sides of the base  12  for providing support when the base  12  is carried. Lateral or central spaced-type support is provided by five nylon straps connecting the uprights to each other.  
         [0044]    The base  12  has formed therein a plurality of rectangular handholds  56  which may be used to pick up the pod  10  without any supporting structure underneath in order to transport the patient. The base  12  has a plurality of grommets  58  formed therein. The grommets  60  are provided to be connectable with elastic tension members  60  having elastic members  62  and  64  hooks for engaging the grommets  58 , as may best be seen in FIG. 6. This allows overlapping base edge portions  70  and  72  to be wrapped around a stretcher  74  to attach the pod  10  securely to the stretcher  74  for transport.  
         [0045]    As set forth above, in order to support the upper portion or top  32  of the pod  10  the plurality of internal supports, stays or ribs has been provided. Each of those stays or ribs is confined within a sleeve  80  comprising a strip  82 . The strip  82  and top  32  along the outside of the pod  10  define a stay-receiving channel having an entryway formed in the bottom thereof. In alternative embodiments the strips  82  may be attached by heat sealing as opposed to being sown.  
         [0046]    In addition the pod  10  includes a plurality of ports including a plurality of small ports for the introduction of EKG apparatus lines, intravenous lines defibrillator lines, suction lines and the like. The ports are positioned in the lower half or bottom of the pod  10  so that the leads may stay connected to the patient whether the pod  10  is open or closed. The small ports  88  are closed with port clips  90  at the ends thereof. In the alternative, when lines are extending through the ports  88  they may be held closed with tape to avoid the communication of contaminants between the inside of the pod and the environment. The ports  88  are typically tapered and may be sown or heat sealed as two halves. The ports  88  are tapered to provide a varying diameter cross-section for receiving a variety of connections thereto.  
         [0047]    An enlarged ventilation port  100  is also provided for receiving a ventilator tube  102  for a respirator. The ventilator tube  102  may be connected to an device for forming an airway to the patient&#39;s respiratory system.  
         [0048]    A pass-through port  110  comprising a double-bagged air lock, is provided with a the top including a large ring  112  with an elastic band  114  surrounding it to engage at least one of a plurality of bags  116  extending into the interior of the opening. The pass-through port  110  may be used to pass plastic bags containing objects through one at a time without breaching the containment of the pod  10 . The pass-through port  110  may be optionally covered with a soft plastic top  118  to prevent material from falling inside one of the bags before it is transferred into the interior of the pod  10 .  
         [0049]    A plurality of drain ports are providing including a drain port  130  and a drain port  132  through which liquids may be drained by gravity by tilting the pod  10  with the patient inside.  
         [0050]    In addition, a pair of air stream or general diaphragm or check-valve type ventilator ports  140  and  142  are provided. The ports only provide communication when they are connected to a fitting which opens the internal check valve. One of which is connected to a ventilator  144  having a pair of filters  146  and  148 . The ventilator is supported by a PVC tubing support  149  that engages an arm of the stretcher. Ventilation air is carried from the head end port  142  to the tail end port  140 . If it is desired to provide positive pressure to the interim of the pod  10  the ventilator  144  is attached to the head end port  142  to provide positive pressure. If it is desired to provide a negative pressure environment in the interior of the pod  10  the ventilator  144  is connected to the port  140  through which it draws air entering the head end port  142 . Thus, the interior of the pod  10  may be run either above ambient pressure or below ambient pressure. When run above ambient pressure the pod  10  is configured for use with a contaminated environment and a uncontaminated patient within the pod. When the pod  10  is run below atmospheric pressure air drawn out of the pod is filtered in the filters  148  and  144  before being released to the environment so that a contaminated patient may not spread contamination.  
         [0051]    In order to obtain access to the patient sealed in the pod  10  a plurality of glove ports  200  are provided. The glove ports  200  are primarily arranged in pairs with a first pair of glove ports  200  on the front wall, a second pair of glove ports  202  on the front wall, two pairs of glove ports on the back and a single glove port  210  at the head end for access to the patient for intubating the patient when necessary. Each of the glove ports  200  of the glove port pairs includes a glove  220 , which may be a substantially unisex latex glove. The glove  220  is connected to a PVC sleeve  222  extending to a glove port opening  224 . In addition, the glove port openings  224  have zipper-type closures  226  associated therewith. The closure  226  has a first flap  228  and second flap  230  with a sealing line  232  similar to an overlapping interlock plastic seal formed thereon. The closure  226  prevents material from falling into the open glove arm during transportation or the like. The glove ports  220  may be used to manipulate the patient within the pod  10  without breaking the barrier and releasing contaminants from the pod  10  into the environment or allowing the contaminants from the environment to reach the patient.  
         [0052]    A further embodiment of the present invention is shown in FIGS.  17 - 19  wherein a pod  300  includes a left transparent PVC pod half  302  and a right transparent PVC pod half  304  joined by a zipper  306  at a center line. The pod  300  includes a plurality of belts  308  for securing the patient to a relatively thick PVC base  310  and includes a plurality of ports  312  having clamps  314  associated therewith for admission of suction lines, defibrillator lines, infusion lines, IV lines, EKG lines and the like. A ventilator port  330  is provided at one end. The pod  300  includes handholds  340  formed in the base thereof. A plurality of stays  350  comprising substantially flat Lexon plastic strips are positioned in sleeves  352  for supporting the pod. The stays are arranged in the stay halves  354  and  356  which provide a tent-like structure.  
         [0053]    The pod  300  works in substantially the same fashion as the pod  10 . It includes a plurality of glove box ports  370  for the admission of the hands and forearms of a doctor or a nurse treating the patient. The glove box ports  370  terminate in gloves  384  connected to PVC sleeves  386  which are attached to an opening  388 . Drain plugs  390  are provided for draining materials from within the pod  300 . A ventilator  400 , which is substantially identical to the ventilator  142  is positioned on a ventilator support  402  and connected to a check valve port  404  for ventilation of the interior of the pod  300 .  
         [0054]    A further alternative pod  500  may be positioned on a stretcher  502  and includes a base  504  with an upper portion  506  and a right transparent half  510  and a left transparent half  512  joined by a zipper closure  514 . A plurality of glove box ports  520 ,  522  and  524  are provided for treating the patient. Each of the glove box ports has an opening  530  with a PVC sleeve  532  attached thereto and a latex glove  534 . The pod  500  includes a plurality of internal supports or stays  550  comprising flattened ribs which are positioned in sleeves in the walls of the bag to support the bag above the patient. The system includes a head-end glove port  600  and an attachment  602  to which a ventilator  604  may be coupled. The pod may be secured to a stretcher by elastic cords  620  and may accommodate a patient  622  therein.  
         [0055]    The present invention may also be incorporated into wraps for civilian use in scenarios involving a limited number of pods for contaminated patients such as might be present in a chemical incident or for persons who would need to have medical attention administered through the wrap. In addition, suits may be provided including a power respirator hood that creates negative pressure within the hood and including rib or other supports for supporting the suit in particular the hood away from the person when the suit is being run in a negative pressure mode to prevent the suit from collapsing around the person.  
         [0056]    While there have been illustrated and described particular embodiments of the present invention, it will be appreciated that numerous changes and modifications will occur to those skilled in the art, and it is intended in the appended claims to cover all those changes and modifications which fall within the true spirit and scope of the present invention.