US 3786809 A
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.
Description (OCR text may contain errors)
[ DEVICE FOR TREATING INFANTS HAVING BREATHING DIFFICULTIES  Inventor: Sotiris Kitrilakis, Berkeley, Calif.
 Assignee: Teena Corporation, Emeryville,
 Filed: Sept. 7, 1972  Appl. No.: 286,968
 US. Cl. 128/191  Int. Cl A61m 16/02  Field of Search... 128/19] R, 191 A, 1 B, 204, 128/202, 203, 185, 145.5, 140, 142, 142.3,
FOREIGN PATENTS OR APPLICATIONS 226,883 10/1910 Germany 128/1423 Primary Examiner-Richard A. Gaudet Assistant Examiner-Henry .l. Recla Attorney, Agent, or Firm-Lothrop & West 5 7 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 infants 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 infants neck. The envelope has a slider-closed major access opening and various fittings for minor access and monitoring connections.
8 Claims, 8 Drawing Figures DEVICE FOR TREATING INFANTS HAVING BREATHING DIFFICULTIES 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 respiratorydistress 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 exampie, 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 2732.
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 accommo dated 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 sup port 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 sur face 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 infants neck and make a relatively air-tight abutment therewith. To that end the diaphragm 16 is provided with a pair of side rings I9 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 airtight 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- 3 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 infants 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 infants head and can come to rest around the infants 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 infants 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 infants 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 infants 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 infants 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 babys 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 babys 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 attach ment 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 infants 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 infants 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 l6 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 infants neck. A range of collar sizes is made available. The diaphragm 71 is slipped over the infants head until the collar is properly positioned around the infants 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.
What is claimed is:
1. A headenclosing, 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 persons 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 persons 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 persons neck located in said diaphragm opening, and means effective when said annular member surrounds a persons neck for inflating said envelope to move said upper wall farther away from the face of a persons 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 I 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 persons neck.
8. A device as in claim 6 in which said ring and said plate are the only rigid supports for said envelope.