U.S. patent number 3,786,809 [Application Number 05/286,968] was granted by the patent office on 1974-01-22 for device for treating infants having breathing difficulties.
This patent grant is currently assigned to Tecna Corporation. Invention is credited to Sotiris Kitrilakis.
United States Patent |
3,786,809 |
Kitrilakis |
January 22, 1974 |
DEVICE FOR TREATING INFANTS HAVING BREATHING DIFFICULTIES
Abstract
A device for treating infants having breathing difficulty has a
rigid, externally grooved ring to one side of which is attached a
clear, flexible, plastic envelope adapted to contain the infant's
head and provided with a connection for a flexible hose leading
breathing gas under pressure from a suitable source into the
envelope. The other side of the ring is spanned by a flexible,
plastic diaphragm overlying the groove and held in engagement with
the ring by a quickly removable contracting band deforming the
diaphragm material into the groove. The diaphragm has an opening
therein encircled by a collar adjustable into close contact with
the infant's neck. The envelope has a slider-closed major access
opening and various fittings for minor access and monitoring
connections.
Inventors: |
Kitrilakis; Sotiris (Berkeley,
CA) |
Assignee: |
Tecna Corporation (Emeryville,
CA)
|
Family
ID: |
23100911 |
Appl.
No.: |
05/286,968 |
Filed: |
September 7, 1972 |
Current U.S.
Class: |
128/205.26 |
Current CPC
Class: |
A61M
16/06 (20130101); A61G 10/04 (20130101); A61M
16/0627 (20140204); A61G 11/00 (20130101) |
Current International
Class: |
A61G
10/04 (20060101); A61M 16/06 (20060101); A61G
10/00 (20060101); A61G 11/00 (20060101); A61m
016/02 () |
Field of
Search: |
;128/191R,191A,1B,204,202,203,185,145.5,140,142,142.3,142.4,142.7,145,297,299
;98/1.5 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Recla; Henry J.
Attorney, Agent or Firm: Lothrop & West
Claims
What is claimed is:
1. A head-enclosing, flexible envelope having an upper sheet and a
lower sheet united on all sides but having a margin defining an
opening at one end, a rigid ring defining an aperture large enough
to pass over a person's head, means for securing said margin to
said ring around said aperture, said ring being of a size to hold
said upper sheet of said un-inflated envelope away from the face of
a person's head inside said envelope, a flexible diaphragm having
an opening and having a margin and disposed in position on said
ring to span said aperture, means for holding the margin of said
diaphragm on said ring, an annular member secured to said diaphragm
in a position surrounding said opening therein, means for
conforming said annular member to a person's neck located in said
diaphragm opening, and means effective when said annular member
surrounds a person's neck for inflating said envelope to move said
upper wall farther away from the face of a person's head inside
said envelope.
2. A device as in claim 1 in which said ring is substantially
elliptical and defines an elliptical shape for the adjacent parts
of said envelope and said diaphragm engaged therewith.
3. A device as in claim 1 in which said annular member is a tube
joined to said diaphragm and having a relatively flat and
continuous inside surface, and means for inflating said tube.
4. A device as in claim 1 in which said envelope is made of
flexible material distensible substantially into a predetermined
shape by the pressure of the gas supplied thereto by said supplying
means.
5. A device as in claim 1 for use on a substantially horizontal
surface in which said ring has a lower supporting surface adapted
to be disposed substantially horizontally and has side surfaces
inclined to the horizontal when said lower supporting surface is
substantially horizontal.
6. A device as in claim 1 including a rigid plate overlying the
exterior of said diaphragm, and means for removably engaging said
plate and said ring.
7. A device as in claim 6 in which said plate includes means
defining a U-shaped cut-out portion adapted to pass a person's
neck.
8. A device as in claim 6 in which said ring and said plate are the
only rigid supports for said envelope.
Description
In recent years there has been considerable progress in treating
difficulties occurring, particularly in newly born infants and
which inhibit their proper breathing. The difficulties are
sometimes referred to as hyaline membrane disease and sometimes
referred to as idiopathic respiratory-distress syndrome. Some newly
born infants, especially infants of very small size and premature,
have substantial difficulty in breathing, to the extent that there
is severe mortality from this cause. Various treatments of the
difficulty have been proposed and utilized with different degrees
of success. Recently, an advance has been made in connection with a
treatment process utilizing a supply of breathing gas, primarily
air and oxygen administered to the infant under superatmospheric
pressure for a protracted period; for example, from say one to
about fourteen days. Germane reports are "Treatment of the
Idiopathic Respiratory-Distress Syndrome With Continuous Positive
Airway Pressure" by George A. Gregory et al. published in the New
England Journal of Medicine, 284:1333-1340 (June 17), 1971, and
"Putting Pressure On Hyaline", Medical World News for Jan. 14,
1972, pages 27-32.
It is therefore an object of the invention to provide a device for
treating infants with breathing difficulty in a successful and
economical fashion.
Another object of the invention is to provide such a device which
does not substantially interfere in any way with the normal care
and treatment of the infant.
A further object of the invention is to provide such a treating
device which can readily be accommodated to different infants.
Another object of the invention is to provide such a device that
can quickly and easily be removed from the infant in the event of
an emergency.
A further object of the invention is to provide an economical
device that can be utilized for one individual and then
discarded.
A further object of the invention is to provide such a device that
is readily stored and is easily portable.
A further object of the invention is to provide a device for
treating infants which can easily be accommodated to variations in
care required by individual infants.
Other objects together with the foregoing are attained in the
embodiment of the invention described in the accompanying
description and illustrated in the accompanying drawings, in
which:
Fig. 1 is a side elevation of a device in actual use;
Fig. 2 is a plan of the device, portions being broken away;
Fig. 3 shows part of the device near the ring;
Fig. 4 is an enlarged cross-section on the line 4--4 of FIG. 3;
Fig. 5 is a partly sectioned elevation showing a backing plate;
Fig. 6 is an elevation of the backing plate;
Fig. 7 is a cross-section of a modification; and
Fig. 8 is an elevation of part of the FIG. 7 device.
While the device can be embodied in various different
configurations and sizes for adults as well as infants and can be
used in a number of widely differing ways, it has with considerable
success been embodied especially for infants as illustrated herein.
In this instance the device is primarily used in connection with a
support 6 such as a table or bed or crib on or within which the
infant 7 can lie. Adapted to rest lightly on the support 6 and to
establish an upright, frame-like structure is a ring 8 (See FIG.
7). Conveniently, this is fabricated of a clear plastic material
and preferably has an elliptical shape such as would result from
cutting the ring obliquely from a circular tube. The interior
surface 9 of the ring is circular cylindrical, as is the exterior
surface 11, except that circumscribing the ring exterior is a
groove 12 half-circular in cross-section.
Secured to the ring by any suitable means, such as an adhesive or
by heat sealing, is an envelope 13 conveniently fabricated of one
or two sheets of transparent, flexible plastic material of any
suitable configuration and preferably secured in edge-closed form
by a peripheral, adhesive or heat seal margin 14. The plastic is
flexible enough so that it can diverge from an initial, relatively
flat condition, particularly at one end, to the generally
elliptical shape of the ring 8 where the envelope and ring
join.
Also adapted to engage the ring 8 is a diaphragm 16 of very soft,
flexible, plastic material of a size that can easily span the ring
and overlie the surface 11, particularly the groove 12. The
diaphragm is held in tight engagement with the ring and is quickly
attachable thereto and detachable therefrom by use of a contracting
band 17. This is conveniently of an elastomeric plastic or rubber.
It is of circular cross-section and, when relaxed, is of slightly
less extent than the ring. The diaphragm is first stretched over
the ring, and the band is then enlarged momentarily, arranged
around the ring and then relaxed and seated in the groove with the
diaphragm intervening. A close, virtually air-tight connection is
thus made, but, if desired, the band can quickly and easily be
withdrawn from the groove and the diaphragm freed from the
ring.
The diaphragm, as particularly shown in FIGS. 3 and 4, has an
opening 18 therethrough of generally circular configuration. The
opening 18 is to pass the head of the infant and then circumscribe
the infant's neck and make a relatively air-tight abutment
therewith. To that end the diaphragm 16 is provided with a pair of
side rings 19 and 21 of quite soft, flexible plastic. Around their
outer peripheral edges 22 the side rings are both heat sealed to
the material of the diaphragm. At their inner peripheral edges 23
the side rings are heat sealed to a continuous tubular strip 24 of
similar, very soft plastic. The side rings and the strip constitute
a deformable and inflatable annulus. Leadking into the chamber 26
defined by the annulus is an air tube 27 having a suitable closure
valve 28 or knot therein.
The envelope 13 is provided with a number of devices for
facilitating its use. Extending for a large fraction of the length
of the envelope on the upper side thereof is a slide closer 31
having a slider 32 thereon. The closer preferably has continuous
margins with air-tight interleaving when closed. When opened by
manipulation of the slider 32 the resulting closer opening is large
enough to receive the hand or hands of an attendant and to afford
adequate access to the head of the infant.
Also passing through the material of the envelope are closable
access fittings 33 and 34 with integrally formed, tightly engaging
caps 36 thereon. Usually but one of the fittings 33 and 34 is
utilized at a time, but they are both provided for ease in
connecting adjacent equipment. When not in use the closed caps 36
are air-tight. One of the fittings; for example, the fitting 33, is
connected tightly to a flexible hose 37 extending to a source 38 of
breathing gas for the infant.
In most instances the breathing gas is supplied from a source of
such gas at superatmospheric pressure. The pressure furnished is
subject to regulation by a controller 39. To monitor the
instantaneous pressure, the envelope is also provided with a
tubular fitting 41 having a detachable closure cap 42. A tube 43 is
attached to the fitting 41 for transmitting the pressure within the
enclosure to the breathing gas source 38. For convenience in
displaying the interior pressure the envelope also has a fitting 44
connected by a tube 46 to a suitable gauge 47. An attendant, even
at a remote location, can observe the pressure and pressure
variations within the envelope. In addition, there is afforded a
closable fitting 48 having a displaceable top 49 so that particular
implements, such as tubes or thermometers, can be introduced to the
envelope in the general vicinity of the mouth and nose of the
infant. Gas discharge can be by leakage or through one of the
fittings at a rate to maintain the desired envelope pressure.
In the use of the device, the diaphragm can be assembled as
described on the ring and with the envelope. When the chamber 26 is
uninflated the infant's head can be introduced through the opening
18 into the interior. Since the material of the diaphragm is
extremely soft and deformable, there is no difficulty in doing so.
Alternatively, the diaphragm in a limp, unattached condition can be
first put over the infant's head and can come to rest around the
infant's neck. The diaphragm can subsequently be secured to the
ring by subsequent attachment of the band 17.
In any case, when the opening 18 loosely encircles the infant's
neck, the valve 28 is opened and a slight pressure is introduced
into the chamber 26 through the tube 27. The chamber is thus
deformed from its flaccid, relaxed state into an inflated annulus
of decreased internal diameter. The wall 24 lies against the skin
of the infant's neck and makes a close abutment therewith. Since
there is no seam in the wall 24, there is no likelihood of any
injury to the infant's skin. The pressure within the chamber 26,
even though slight, is sufficient to ensure either a very moderate,
planned leakage between the wall 24 and the infant's neck or
substantially no leakage at all. The flexibility of the diaphragm
and of the associated annulus is such that the infant can move with
respect to the apparatus or can be moved with respect to it without
any special strain or force being exerted and certainly without any
injury to the infant.
The envelope is put into a closed condition by operation of the
slider 32 and connection of the various tubes 43 and 46 and
particularly of the tube 37. The closures 36 and 49 that are not in
use are snapped shut. The envelope is thus substantially sealed
hermetically. By operation of the regulator 39, a regulated supply
of breathing gas is furnished through the tube 37 and inflates the
interior of the envelope. This then takes on a shape different from
its collapsed, relatively flat shape and arrives at a configuration
substantially as shown in the figures, so that the envelope is away
from any contact with the baby's face and at least most of its
head. Should the air pressure at any time suddenly fail and the
envelope not be subject to internal pressure, the extent, position
and stiffness of the ring 8 are sufficient so that the plastic
envelope cannot fall into contact with the baby's face and obstruct
its breathing.
By observing the gauge 47 and by regulating the controller 39,
there can be supplied to the infant a continuous or pulsating
stream of breathing gas at a superatmospheric pressure. This is
effective, as and to the extent set forth in the publications above
noted, to foster the continued existence of the infant and
drastically to redice the mortality otherwise occurring.
In some instances the apparatus is slightly modified by the
provision of an intermediate humidifying attachment 51 in the tube
37. The attachment is supplied with moisture through a tube 52 and
affords the desired humidity within the envelope.
It is intended that the infant reside in the envelope for a period
of several days. To permit the infant to be cared for during that
time, the slider 32 is intermittently moved to afford an opening.
From time to time the fitting 48 can be utilized for a feeding
tube, for other intubation, for thermometric measurement and the
like.
When the infant is able to live outside of the envelope, it is a
simple matter to remove the various attachments, remove the band 17
to detach the membrane, deflate the chamber 26 so that the opening
18 enlarges, and to withdraw the membrane and envelope from the
infant. The plastic portion of the structure; that is to say, the
ring, the diaphragm and the envelope, can be appropriately
sterilized for reuse or are economical enough so that they can be
completely discarded.
It is sometimes the case that the diaphragm 16 is so soft that the
internal pressure causes excessive external bulging. To prevent
this and to serve as an additional stabilizer, there is provided,
as shown in FIGS. 5 and 6, a stiff plastic baking plate 61. This
has three rolled or inturned edges forming flanges 62, 63 and 64
arranged frictionally to engage end overlie the adjacent positions
of the assembled ring 8 and band 17. The plate 17 has an inverted
U-shaped cut-out portion 66 of adequate extent to pass the infant's
neck.
When the parts are otherwise assembled, the backing plate 61 is
slipped into position, as shown in FIG. 5, and underlies the
diaphragm 16. The diaphragm under pressure deforms against the
backing plate and is supported even against large internal
pressure. Even so, the backing plate can be quickly removed from
the ring 8 for emergency disassembly.
If the pneumatic annulus around the infant's neck is not desired,
it is possible to substitute an arrangement as shown in FIGS. 7 and
8. In this instance, the ring 8 and contracting band are as before
but retain a soft rubber diaphragm 71 generally like the diaphragm
16 and used with a backing plate 61 if desired. The diaphragm 71 is
formed with a slightly conical soft rubber, preferably integral,
collar 72 having a size only slightly larger than the infant's
neck. A range of collar sizes is made available. The diaphragm 71
is slipped over the infant's head until the collar is properly
positioned around the infant's neck. This alone may afford a
sufficiently close fit. But is is usually supplemented by a strip
73 of flexible material faced with hooks and loops, such as a
"Velcro" fastener. One end of the strip 73 is secured to the collar
72. The other end of the strip, in use, is lapped over the secured
end as far as necessary to reduce the collar 72 to the proper neck
size for the infant.
With either apparatus an environment can be easily and quickly and
economically furnished to alleviate breathing difficulties and to
provide an ambiance of selected pressure, moisture, temperature and
quietness without interfering with easy observation, monitoring and
care.
* * * * *