Sacral topical hyperbaric oxygen chambers

A hyperbaric oxygen treatment apparatus for use by a patient recumbent on a bed comprising, an openface chamber and an adjustable rigid support therefore, the chamber having a closed rear side and an open front side, the opening in the front side of the chamber being defined by a forwardly projecting first gasket presenting a resilient feather edge which is adapted for substantially gas-tight engagement with a human body surface along a line surrounding an area to be treated, and the rear side of the chamber being provided with fittings for connection to the support and to a controlled source of oxygen, and the rigid support including articulated members connecting the chamber to at least one bed rail.

This invention relates to a controlled pressure oxygen treatment system 
which includes an open-walled chamber adapted to be applied to a portion 
of the surface area of a human body, normally including part of the trunk, 
so that said body area closes the chamber, and a gas (oxygen) supply 
circuit, with controls, adapted to supply gas to the chamber automatically 
in pulses of predetermined frequency, duration and pressure. 
It is known to use hyperbaric oxygen topically to treat pressure sores, 
wounds, skin lesions, decubiti and ulcers, chambers for this purpose being 
shown and described in Fischer U.S. Pat. Nos. 3,744,491, July 10, 1973 and 
4,003,371, Jan. 18, 1977. In these chambers, the flow of oxygen past the 
enclosed leg or arm of a patient is continuous, at a low constant pressure 
of 22 mmHg, for example, and is continued for several hours a day 
(preferably six to eight) over periods which may average several weeks, to 
aid in the healing of various lesions. 
Studies have now revealed that the treatment time for ulcerations and 
lesions originating from various etiologies can be substantially reduced 
by resorting to the use of pulsating oxygen treatment, as in the oxygen 
chamber disclosed in applicant's copending application Ser. No. 
06/052,488, filed June 27, 1979. Actual trials of that system in a leading 
hospital have shown a median healing time of 19 days, substantially less 
than the time required for more conventional treatment. 
It is accordingly an object of the present invention to provide a treatment 
chamber for a portion of a human body specially adapted for use with a 
pulsed oxygen supply. Suitable oxygen supply circuits are disclosed in 
Fischer Applications Ser. No. 858,960 (now abandoned) and its C.I.P., Ser. 
No. 06/052,488, filed June 27, 1979. 
It is another object of the invention to provide such a chamber which is 
designed to use the hospital oxygen supply, to which it can be connected 
and from which it can be removed in seconds. 
It is a further object of the invention to provide a chamber which is of 
simple construction, sturdy and easily cold-steralized. 
It is another object of the invention to provide an open-walled chamber 
which is adapted to be applied extracorporeally to the ulcerated body, the 
surface of which completes the closure of the chamber. 
It is a still further object of the invention to provide such a chamber 
with readily interchangeable windows, varying in size, to accommodate 
lesions of different sizes without overexposure of healthy areas to the 
oxygen. 
It is yet another object of the invention to provide certain improvements 
in the form, construction and arrangement of the several parts wherey the 
above-named and other objects of the invention can readily be achieved. 
The invention accordingly comprises the features of construction, 
combination of elements and arrangement of parts which will be exemplified 
in the construction hereinafter set forth, and the scope of the invention 
will be indicated in the claims.

Referring to the drawings, the manner of use of the chamber in treatment of 
a sacral lesion is illustrated in FIG. 1 wherein the patient is shown 
lying on her left side with the sacral area in a substantially vertical 
position. The oxygen chamber, shown generally at 11, is held in operative 
position against the area to be treated by means of the chamber support 
stem 12, adjustably fixed on the bed stand 13 which, in turn, is supported 
on upper and lower bed rails by the adjustable upper and lower hooks 14, 
15. A gas (such as O.sub.2) is supplied to the chamber by a tube 16 which 
may be provided with an in-line humidifier 17 and is connected to the 
control box 20. A second tube 21 connects the interior of the chamber with 
a pressure sensing instrument (not shown) in the control box 20, and the 
third tube 22 is the oxygen relief tube. 
The control box 20 may suitably correspond to the control apparatus 72 
shown in FIGS. 8 and 9 of the copending application of Fischer, Ser. No. 
06/052,488, under which the owner of the present application is licensed, 
said apparatus being adapted to supply a pulsed flow of oxygen to a 
treatment chamber at controlled rates and pressures, as explained below. 
The support arm 12 is coupled centrally to the back of the chamber by a 
releasable and adjustable ball and socket joint 24, the ball element 25 
being mounted on a screw 26 having a knurled head 27, by means of which 
the screw can readily be engaged with and disengaged from the internally 
threaded forward end of the stem 12. The engagement of the stem with the 
bed stand 13 is effected by means of a fitting which includes a collar 28 
rotatable and slidable on the bed stand 13, a stem support bracket 29, the 
collar and bracket each having a set screw 30, 31, respectively, and a 
bracket hanger 32 with its adjusting screw 33. This fitting makes possible 
universal adjustment of the support stem 12 in relation to the bed stand 
13. 
The upper hook is engaged with the upper end of the bed stand 13 by means 
of a screw 35, the hook being shaped to engage a bed rail firmly when the 
screw is tightened. The lower hook 15 is mounted on the stand 13 by means 
of a sleeve 36, an adjusting screw 37 and a hook tightening screw 38 which 
holds the hook in tight engagement with a lower bed rail. The lower hook 
is shown in FIGS. 1 and 2 as being directed downwardly, to engage the bed 
rail from above, but its orientation can be reversed if desired by 
reversing the position of the sleeve 36 on the bed stand. 
The oxygen chamber 11 comprises a flat, circular rear wall 40, an annular 
wall 41 having one edge set in a groove 42 adjacent to the periphery of 
the rear wall, and an annular rim 43, rabbetted at 44 to receive the 
thickened base of a resilient sealing gasket 45. The feather edge 45' of 
the gasket defines the opening of the chamber which is to be closed by 
contact with the area of the patient's body containing a lesion or the 
like to be treated, and this edge, therefore, projects a plane farthest 
from all other parts of the chamber. The rim 43 is grooved at 46 to 
receive the front edge of the wall 41 and has an additional annular groove 
47, radially outward from the groove 46, for a purpose described below. 
The rear wall 40 is provided with male or female fittings to engage tightly 
with the complementary fittings on the tubes 16, 21 and 22, to provide 
operative connection of the chamber to the control box 20. 
The opening defined by the edge 45' of the gasket corresponds to the 
maximum body surface area which can be treated. It is known, however, that 
the smallest size opening possible gives the best results as long as there 
is no direct contact of the gasket with the wound to be treated. The 
apparatus therefore includes one or more (preferably two) auxiliary rings, 
as shown in FIG. 9, each having a flat annular plate 50 and a tapered 
gasket 51 set in a rabbet 52 around its central opening. The feather edge 
51' defines a much smaller opening than the edge 45' and can be 
advantageously used on smaller wounds. The manner of use of the separate 
rings is illustrated in FIG. 10 where the plate 50 is applied to the front 
of the gasket 45 and is held there forcefully by the engagement of spring 
clips 55 which are carried on an elastic belt 56, resting normally around 
the periphery of the wall 41 (FIG. 7), but available to be snapped into 
the groove 47 and a complementary groove 53 in the face of the plate 50 
(FIG. 10) adjacent to its peripheral edge, when an auxiliary ring is used. 
The fixed rim 43 and auxiliary ring 50, with their gaskets 45 and 51, 
respectively, are shown as being annular in form, but it will be 
understood that other forms such as oval, square or elongated could be 
used in special situations, if desired. 
If the patient is to be treated in a bed without side rails, the bed stand 
13 can be supported very firmly by means of the under mattress plate 58 
which is T-shaped in plan view (FIG. 5) and has an integral upstanding 
socket 59 at its "stem" end to receive the lower end of the stand. The 
mattresses normally used on beds adapted for therapeutic treatments are 
normally very firm and the shape of the plate is such that its tendency to 
tilt in any direction is negligible. 
While it is possible for a patient to remain immobile in a position such 
that a lesion on the like is retained within the opening of a gasket 45 or 
51 and with the body surface in sealing contact therewith, greater 
security can be provided by the use of a support belt such as that shown 
in FIG. 11. The belt has two straps 60 with buckles 61 and a pair of 
cross-straps 62 which leave a square opening of a size to receive the 
various tube terminals and chamber mounting means which are located on the 
rear wall 40. The chamber is placed carefully in its desired position on 
the patient's body and the straps 60 are buckled around the body just 
tightly enough to hold the chamber in place. 
The oxygen chamber operates as determined by the apparatus in the control 
box 20, on the principle of pulsed pressure, consisting of a compression 
phase followed by a quick decompression phase. The control apparatus is 
connected to a standard unrestricted 50 psi oxygen source and is set, 
preferably, to operate with a 10-second compression phase (from 0 mmHg to 
40 mmHg) followed by a one-second decompression phase (from 40 mmHg to 0 
mmHg). If desired, the upper figure can be varied below 40 mmHg but the 
compression phase should not be operated below 22 mmHg. The humidification 
of the chamber, by means of humidifier 17, should achieve at least 50% 
relative humidity. 
The recommended treatment time usually consists of two sessions per day, 
each lasting one hour, unless the physician orders otherwise. Treatment 
with this controlled pressure oxygen delivery system is not a substitute 
for proper primary treatment of the basic disorder and proper nursing 
care, but can be a valuable adjunct to the standard medical and/or 
surgical management of the patient. 
It will thus be seen that the objects set forth above and those made 
apparent from the preceding description are efficiently attained and, 
since certain changes may be made in the construction shown an described 
without departing from the spirit and scope of the invention, it is 
intended that all matter contained in the above description or shown in 
the drawings shall be interpreted as illustrative and not in a limiting 
sense.