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.
Unlike conventional weapons, exposure by rescuers to victims of chemical or biological attack can adversely affect these rescuers. To avoid such affects on rescuers, including medical and transport personnel, it is necessary to isolate the victims of the attack. Additionally, it may be necessary to transport non-contaminated patients through zones that are already contaminated or are under the threat of chemical or biological attack. Meanwhile, in the civilian sector it is increasingly required to treat all emergency patients as potentially infectious and hazardous to personnel and equipment. This requires the use of isolation techniques during transport and treatment.
In addition to chemical attacks, highly infectious diseases, for which no cure has been found, require isolation. For example, severe acute respiratory syndrome (SARS) is easily transmitted, and has severe consequences. Containment is necessary to prevent this disease from spreading.
U.S. Pat. Nos. 6,241,653, 6,321,764, 6,418,932 and 6,461,290 describe various aspects of known containment devices. Each of U.S. Pat. Nos. 6,241,653, 6,321,764, 6,418,932 and 6,461,290 is hereby by incorporated by reference.
In the known containment devices, a containment wall may be supported away from a patient through hoop-like supports. Each support is attached to the containment wall, with a plurality of supports provided along the length of the containment wall. The supports pull the containment wall away from the patient. However, the containment device must be transported before use, and it is difficult to transport the device with the supports fixed to the containment wall. Also, it is difficult to secure the supports to the containment wall in the field. Additionally, the bottoms of the supports are biased away from one another. This could cause the supports to separate from the containment wall (if provided on the outside) or puncture the containment wall (if provided on the inside).
Known containment devices are also have problems associated with sealing together the open parts of the containment wall. Various proposals have been brought forward regarding closing a top of the containment wall to a bottom of the containment wall. However, it is still difficult to maintain a seal between the top and bottom of the containment wall, which seal will not unexpectedly open and will contain contaminants within the device.
One of the primary purposes of a containment device is to be able to treat the patient while avoiding infection. Although the patient is usually held within the containment device temporarily, there is a need for the ability to provide at least first aid services. Without the ability to interact with the patient, a containment device is somewhat useless. A simple plastic wrap could be used around the body of the patient and an oxygen mask could be placed around the face of the patient. Although access to the patient is a concern, the known devices have not provided sufficient flexibility. The known devices gave the healthcare worker insufficient latitude in deciding how to treat the patient. In addition, many of the known treatment methods could not be administered to an infectious patient without the healthcare worker risking infection.
To possibly address the above concerns and/or different concerns, the inventor proposes a collapsible, protective containment device isolates a patient in a controlled environment. The containment device has a flexible containment wall, a closure device an air ventilation device and a plurality of ribs. The flexible containment wall is expandable from a collapsed state to define an interior region for receiving at least a portion of a patient therein and providing an impermeable barrier about the portion of the patient, for at least a selected contaminant. The closure device closes the containment wall about the patient to provide a substantially airtight interior region. The air ventilation device provides a gas comprising oxygen to the substantially airtight interior. The plurality of inflatable ribs provided along a length of the containment wall, the inflatable ribs defining one or more air compartments separate from the interior region within the containment wall, the one or more inflatable ribs supporting a pressure sufficient to support the containment wall away from the patient.
The closure device may include a first manipulatable zipper seal, first and second flaps and an adhesive flap. The first manipulatable zipper seal is formed from first and second strips provided respectively on the first and second ends of the containment wall. The first and second strips have reclosable interlocking profiles to seal the first and second ends of the containment wall to one another. The first and second flaps are provided on the containment wall and have a second manipulatable zipper seal formed from third and fourth strips provided respectively on the first and second flaps. The third and fourth strips having reclosable interlocking profiles to seal the first and second flaps to one another. The adhesive flap is provided on the containment wall such that the first flap is attached to the containment wall between the first end of the containment wall and the adhesive flap. The adhesive flap has an adhesive strip and a release layer to seal the adhesive flap to a sealing position on the containment wall after the release layer have been removed. The sealing position is located such that the second flap is attached to the containment wall between the second end of the containment wall and the sealing position.
To treat the patient, the containment device may have an adapter, a removable container, an injection unit, and a cap. The adapter is sealed to a flexible sleeve and has an inner circumference that defines an aperture. The removable container holds patient fluid. The removable container fits within the aperture in the adapter and has a sealed end that temporarily opens when pierced. The injection unit is fastened to the flexible sleeve and has first and second ends. The first end has a needle to pierce the patient's skin, and the second end is in fluid communication with the first end and has a tip to pierce the sealed end of the container. The cap connects to the adapter to hold the second end of the injection unit within the sealed end of the container.
For flexibility in treatment, the containment device may have an aperture in the containment wall and first through third aperture sealing units. The first aperture sealing unit seals the aperture from the at least one contaminant and provides a first access to the patient. The second aperture sealing unit seals the aperture temporarily while the first aperture sealing unit is still attached to the aperture. The third aperture sealing unit covers the aperture while the second aperture sealing unit is attached to the aperture. The third aperture sealing unit provides a second access to the patient.
To improve access, the containment device may have a sleeve extending form the containment wall to define an aperture in the containment wall. In this case, the sleeve has inner and outer circumferences. The outer circumference has inner and outer grooves exterior to the interior region. The inner groove accommodates a first aperture sealing unit which provides access to the patient. The outer groove accommodates a third aperture sealing unit which provides access to the patient. The inner groove is closer to the containment wall than the outer groove. The inner circumference of the sleeve receives a second aperture sealing unit while the first aperture sealing unit is being replaced by the third aperture sealing unit.
The containment device may have a call unit provided within the interior region. The call unit has an alert unit and an activation mechanism manipulatable by the patient to trigger the alert unit and request patient attention from outside of the interior region.
These and other objects and advantages of the present invention will become more apparent and more readily appreciated from the following description of the preferred embodiments, taken in conjunction with the accompanying drawings of which:
Reference will now be made in detail to the preferred embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like reference numerals refer to like elements throughout.
A patient would lie within an interior region 30. The patient would be placed within the interior region 30 if that the patient would otherwise have a potential to create a condition of harm to others, for example by spreading an infectious disease. Reference numeral 40 represents a stretcher, which could be used to transport the patient to a facility that has more permanent equipment for infection isolation.
The top 20 and bottom 10 together define a containment wall. The isolation device or “pod” is shown as being open. Accordingly, a lip 200 of the top 20 is not in contact with the bottom 10. When the containment device is occupied by a patient, the top 20 and bottom 10 would ordinarily be sealed to one another.
The containment device has access holes 50, which allow access to the patient. Glove 60 represents one way to access the patient. The glove 60 has an outer end which is sealed to the corresponding access hole 50 such that contaminants cannot escape to the environment through either the glove 60 or the corresponding access hole 50. A medical worker can reach his hand into the access hole 50, fit his hand into the glove 60 and provide assistance to the patient.
In one embodiment, the containment wall is formed from a flexible material. When the top 20 and bottom 10 are sealed to one another, pressure inside the containment device may be less than or greater than the pressure outside of the containment device. If the interior region 30 is at a positive relative pressure, then the pressure assists in maintaining the containment wall away from the patient. However, even if such a positive pressure condition exists, it is still necessary for the containment wall to be supported while loading the patient into the device. To support the flexible material of the containment wall away from the patient, inflatable support ribs 100 are provided.
As can be seen, all of the ribs are connected. When the containment device is collapsed for shipping prior to use, the ribs would be deflated. However, when preparing the containment device for use, the ribs would be inflated through an inflation unit 130. Although the exact positioning of the inflation unit 130 may be varied, it is shown on the back side of the containment device, towards the bottom of one of the back lateral ribs 120.
When it is necessarily to inflate the ribs 100, the inflation unit 130 is activated, perhaps by connecting a pump to the inflation unit 130, by triggering a gas cartridge located within the ribs 100 or by puncturing an external gas cartridge, which is sealed to the inflation unit 130.
Regardless of the source, the gas travels from the inflation unit 130 toward the intersection of the corresponding back lateral rib 120 and the top back rib 110. From this intersection, the gas permeates throughout the ribs 100 to inflate each of the ribs.
One-way membranous valves may be provided to isolate ribs from one another. For example, if each rib is connected to the top back rib 110, a one-way membranous valve may be provided at the intersection of each rib and the top back rib 110. The top back rib 110 would be unobstructed so that air can freely flow through the top back rib 110. However, the one-way membranous valves only allow air to flow in a direction from the top back rib 110 to the lateral ribs. In this manner, if one of the lateral ribs 100 is punctured, air cannot flow into the punctured rib from the remainder of the ribs. Air can only flow out of the punctured rib. With the provision of one-way membranous valves, deflation of the ribs may be more difficult. However, the containment device may be designed as a one-time use device, which can be disposed of by hazardous waste disposal personnel.
In
The above describes the ribs as being filled with a gas, such as air or carbon dioxide. If the patient has to be transported by aircraft, there could be significant pressure changes between when the patient is loaded into the containment device and when the patient is transported. In this case, it would be highly undesirable for the ribs to puncture or collapse under the changed pressure conditions. To prevent this, the ribs 100 may alternatively be filled with a polyurethane injection foam sealant similar to the building insulation foam sold under the name Great Stuff™ by Dow Chemical Corporation of Midland Mich. This foam spreads from the inflation unit 130 to the remainder of the ribs. After injection, the foam hardens.
In order to seal the top half 20 to the bottom half 10, there are two reclosable interlocking profile zipper seals and one adhesive seal. A first interlocking zipper seal is formed between a top lip 220 and a bottom lip 210. Both the top and bottom lips 220, 210 have interlocking seal profiles 230. The shape of the profiles are complimentary such that when the two profiles are pushed together, a seal 235, similar to that used for food storage bags, is created. In addition, a second zipper seal is formed between a top primary flap 240 and a bottom primary flap 250. As with the top and bottom lips 220, 210, the top and bottom primary flaps 240, 250 have interlocking seal profiles 230. The profiles are complimentary, such that a similar seal 235 can be formed between the top and bottom primary flaps 240, 250. As a further measure of safety, an adhesive flap 260 is provided. At the end of this flap, an adhesive member 262 is provided. The adhesive member is shown in
In
In
As to the sealing procedure, first, the top and bottom lips 220, 210 are sealed to one another. To do this, the top and bottom lips 220, 210 are brought into close contact with each other by pulling back the primary flaps 240, 250 and the adhesive flap 260 from their positions shown in
Once the seal between the top and bottom lips 220, 210 has been formed, then the top and bottom primary flaps 240, 250 are sealed to one another in a similar manner. Specifically, the top and bottom flaps are brought into contact with each other in the vicinity of the interlocking seal profiles 230 provided thereon. A zipper 236 is attached (if not already attached) between the top and bottom primary flaps 240, 250 in the vicinity of the respective interlocking seal profiles 230. The zipper 236 is drawn along the intersection of the two flaps to create a seal behind the slide.
After the top and bottom lips 220, 210 and the top and bottom primary flaps 240, 250 are both sealed, then the adhesive flap 260 is secured. In
In order to close the reclosable seals, manual pressure can be used. Alternatively,
The adapter 310 allows the glove 60 to be replaced with a new glove. This may be desired, for example, when there is damage to an original glove. The adapter 210 also allows the glove 60 to be replaced with various other care devices, such as a blood sampling device. All of this can be done without allowing contaminants to escape from the interior region of the containment device.
Replacement of a glove 60 will now be described. Referring to
Referring to
To replace the glove 60 with a difference accessory, the tie wrap 330 is removed. If there is an O-ring within the first O-ring groove 322, this O-ring is removed. At this point, only the O-ring in the second O-ring groove 324 is sealing the glove. Then, the outer border 61 of the glove 60 is slid out of the groove 316 and moved to the top 340 of the adapter 310 until the outer border 61 retracts to a smaller diameter. The glove 60 is moved into the adapter 310 with the O-ring 326 still resting within the second O-ring groove 324. Then, a new accessory is fit over the adapter 310. Like the glove 60, the new accessory is a resilient, stretchable sleeve with an outer border 61. The outer border 61 of the new accessory is fit into groove 316. Then, a tie wrap and at least one O-ring are used to secure the new accessory. When inserting an O-ring 326 into the second O-ring groove 324 for the new accessory, the old O-ring, which held the glove 60, is pushed out of the second O-ring groove 324. At this point, the glove 60 is released from the adapter 310 so as to fall within the interior region 30 of the isolation device. The glove 60 can remain within the interior region without disturbing the patient. Since the containment device may be 100% disposable, it is possible for the glove 60 to never be removed from the interior region 30.
Ordinarily, a glove 60 provides a seal between the patient and the caregiver. However, if something should puncture the glove 60, the seal could be compromised.
Inserting the temporary seal device is the first step when a glove 60 or other accessory is damaged. After the temporary seal device is installed, the tie wrap 330 can be removed. With the temporary seal device in place, the risk of contamination is substantially eliminated. The outer border 61 of the glove 60 can be slid out of the groove 316 and over the top end 340 of the adapter 310. After the outer border 61 is moved over the top 340, a new accessory is fit over the glove 60. The outer border 61 of the new accessory is fit into groove 316.
At this point, the new accessory can be secured to the adapter 310 with a tie wrap. The compression mechanism 380 is manipulated through the resilient stretchable sleeve of the new accessory so as to release the temporary seal device from the inner circumference of the adapter 310. Then, both the damaged glove 60 and the temporary seal device are moved into the containment device. This displaces the O-ring of the old glove 60 which is still resting within the second O-ring groove 324. The temporary seal device and the damage glove 60 can be moved into the containment device from the top end 340 using manual manipulation and the flexible characteristics of the new accessory attached to the adapter 310. The damaged glove 60 and temporary seal device can also be pulled into the interior of the containment device from the bottom end 350 using a glove provided on an adjacent access hole.
A groove 318 is provided on the bottom side 350 of the adapter 310, below the extension ring 320. When the adapter 310 is connected to the containment device, the groove 318 is within the interior of the containment device. The groove 318 can accommodate an outer border 61 of a glove or an outer border of another accessory. However, because the groove 318 is located toward the bottom end 350, the glove or other device which is fastened to the groove 318 would ordinarily not be replaceable. That is, once a glove is removed from groove 318, it would be difficult to place another glove around groove 318.
The injection unit 420 may have a valve mechanism such that blood can only flow out of the piercing outlet device 428 when in contact with the reclosable seal 432. Ordinarily, the injection unit 420 would be secured to the blood sampling adapter 400, perhaps with an adhesive or heat welding. With the valve mechanism, the injection unit 420 maintains a containment seal between the patient and the health caregiver. Because the containment device shown in
The communication link 520 is connected to the alert device 530, as described previously.
The invention has been described in detail with particular reference to preferred embodiments thereof and examples, but it will be understood that variations and modifications can be effected within the spirit and scope of the invention.
This application is based on and hereby claims priority to U.S. Provisional Application Ser. No. 60/479,853 filed on Jun. 20, 2003, the contents of which are hereby incorporated by reference.
Number | Date | Country | |
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60479853 | Jun 2003 | US |