Hyperbaric oxygen patient treatment system with therapeutic...

Surgery – Respiratory method or device – Hypobaric body chamber

Reexamination Certificate

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C005S713000, C005S909000

Reexamination Certificate

active

06484716

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to patient treatment systems. More particularly, the invention relates to a hyperbaric oxygen patient treatment system having integrated therein a therapeutic patient support.
BACKGROUND OF THE INVENTION
Hyperbaric oxygen therapy (HBOT) dates back to as early as the 1600's when compressed air was delivered to an airtight room for the treatment of various ailments. The first contemporary HBOT programs, however, were developed in the early 1900's when the delivery to the body of increased oxygen concentrations was found to be an effective treatment for decompression sickness, commonly known as the bends. Subsequently, HBOT was approved for the treatment of carbon monoxide poisoning where it has been shown to produce recovery with little or no neurological deficit.
While HBOT is well known as the treatment of choice for decompression sickness and has a significant history in the treatment of carbon monoxide poisoning, HBOT is only recently emerging as part of other treatment regimen.
Despite the controversy surrounding the acceptance of HBOT as an element of newer protocols, HBOT has been shown to be invaluable in certain situations. One such area is in the treatment of selected non-healing wounds and compromised skin grafts and/or flaps, where the hyperoxygenation of the plasma concomitant HBOT treatment is particularly beneficial in bacteria reduction and infection control.
It has been found that HBOT has bacteriostatic and bactericidal effects on anaerobic bacteria. In particular, it is known that HBOT can inhibit the toxins produced by the synergistic bacteria found in necrotizing fasciitis—
staphylococcus aureus
and bacterioides. Although the host soft-tissue infection is considered rare, the lifesaving and limb-preserving role of HBOT in its prevention is not generally disputed. Likewise, HBOT is known to contribute to the control of aerobic infections. In particular, the increased oxygen levels resultant HBOT helps ensure the necessary oxygen required for the neutrophils to kill bacteria. It is also known that the antimicrobial effect of some antibiotics can be enhanced by HBOT. In summary, it is clear that HBOT can play a significant role in the management of wounds with acute or chronic infection.
Unfortunately, the ability to provide the patient with the beneficial HBOT does not come without difficulty. Necrotizing fasciitis usually occurs postoperatively, after trauma or after inadequate care of abscesses or cutaneous ulcers. Because patients falling into any of these categories often require therapeutic support surfaces to prevent further skin deterioration and/or related complications, it has heretofore been generally impractical to incorporate HBOT into the treatment regimen. Even if the hospital hosting the patient were one of the few having the very expensive HBOT capability, most hyperbaric chambers are not compatible with the presently available therapeutic surfaces. In the very rare case of a hospital having an entire room dedicated to HBOT known therapeutic surfaces are nonetheless rendered ineffective by the tendency for the increased pressure to compress the patient support surface. As a result, those patients with the most severe skin deterioration, and therefore most likely to benefit from HBOT, are most often excluded from HBOT due to the critical need for support upon a therapeutic skin treatment surface.
Accordingly, it is a primary object of the present invention to improve generally over the prior art by providing a platform for HBOT having integrated therein a fully compatible therapeutic patient support surface.
It is a further object of the present invention to make HBOT more readily available by providing a platform for HBOT that is inexpensive and within the capital budgets of the majority of hospitals.
It is yet another object of the present invention to still further increase the availability of HBOT by providing a platform for HBOT that is easily transportable and no or little more space consuming than presently available standard hospital beds.
It is still further an object of the present invention to facilitate the critical care of patients requiring HBOT by providing a platform for HBOT that is readily interfaced with standard treatment instrumentalities such as, for example, cardiac monitors and intravenous (IV) flows.
Still another object of the present invention is to facilitate the provision of HBOT to patients by providing an improved platform for HBOT that a mattress that reduces patient interface pressures despite the hyperbaric environment.
Finally, it is an object of the present invention to promote the general patient care by providing a platform for HBOT that is sensitive to fears and concerns of the already distressed patient such as, for example, the claustrophobia often experienced by patients subjected to HBOT.
SUMMARY OF THE INVENTION
In accordance with the foregoing objects, the present invention—a hyperbaric oxygen patient treatment system—generally comprises an inflatable enclosure for encasing a patient to receive a hyperbaric treatment and an inflatable mattress system positioned at least partially within the inflatable enclosure for supporting the patient during the hyperbaric treatment. The inflatable enclosure is adapted to withstand an internal pressure sufficient to deliver increased oxygen concentrations to the patient's body. In part, this pressure resistance is enhanced by utilizing the teachings of U.S. Pat. No. 4,728,551, issued Mar. 1, 1988 to Jay, and U.S. Pat. No. 5,362,543, issued Nov. 8, 1994 to Nickerson, and related patents (collectively, the “RIK Patents”), which disclosures are incorporated fully herein, as if fully set forth, by this reference thereto, as such teachings have evolved to become commercially available from the parent company of the assignee of both listed patents and the present invention, Kinetic Concepts, Inc., of San Antonio Tex. To prevent claustrophobic effects during periods of non-treatment without the highly undesirable requirement for transferring the patient the inflatable enclosure is adapted to be opened such that the patient is substantially uncovered.
The inflatable mattress system is adapted to compensate for the increased pressure within the inflatable enclosure during hyperbaric treatments. In at least one embodiment, where the inflatable mattress system includes an inflatable cushion, the inflatable mattress system is adapted to increase the pressure within the inflatable cushion in response to an increase in the pressure within the inflatable enclosure. Similarly, the inflatable mattress system is adapted to decrease the pressure within the inflatable cushion in response to a decrease in the pressure within the inflatable enclosure. In at least one embodiment, a control system is provided for effecting a desired interface pressure between the inflatable cushion and the patient and, thereafter, maintaining the desired interface pressure in the face of changing pressure within the inflatable enclosure. The use of RIK fluid aids in achieving this goal, as a RIK fluid containing cushion is highly resistant to, and therefore largely independent the compressive effects of the increased ambient pressures associated with HBOT.
In providing a therapeutic surface, the inflatable cushion may comprise a low air loss cell and/or there may be provided a plurality of inflatable cushions that cooperate to form a low air loss patient support surface. In the case where the patient surface is formed from a plurality of transversely oriented elongate cells, very desirable therapeutic treatments such as the well-known pulsation therapy may be provided to prevent breakdown of the skin tissues concomitant with high interface pressures. To provide the pulsation therapy, the inflatable mattress system is adapted to produce intermittent pressure differentials between adjacent transversely oriented elongate cells.
In order to simplify the design of the integral HBOT-therapeutic surface system, a source of pressurized gas in f

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