CA1200722A - Permanent adapter - Google Patents

Abstract

Abstract of the Disclosure An adapter for connection between an oxygen flowmeter and a water bottle whose contents humidify oxygen fed to a patient. An audible duckbill valve is mounted on a valve seat transverse to the longitudinal axis of the connector. When oxygen pressure through the connector becomes excessive, the valve opens, producing an audible sound to alert an attendant to the condition.

Description

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PERMANENT ADAPrrER

Bac~ ound of the Inventlon The present invention xelates to an adapter for a humidifier used in respiratoxy apparatus.
Inhalation therapy is frequently used for patients suffering from such diseases as em~hyse~a! stroke, heart stoppage, drowning~ and a variety of other applica~ions which require the administration of eithex pure oxygen or a high percentage of ~xygen or otherlr~dicaments administered through inhalation therapy.¦
Hul~idifiers are employed in the respiratory apparatus. The patient inhales a gas-liquid mixture from the humldifier, which is efeective in moistening the gas that is passed through the humidlfier and discharged therefrom in a manner to introduce the moistened gas, such as oxygen or air, into a person's respiratory system. The gas is humidified so as to prevent dessication of the respiratory tract or membranes during treatment over a prolonged period o~ time.
There has been a problem in the past with medical humidifiers in reliably determining when humidified gas ~as inadvertently cut off from the patient. This often happened when the oxygen tube leading to the patient's mask became kinked.
Thus, while ,it ~p~eared that the patient was still receiving tne oxygen or~ ther humidified gas, he was in effect cut off from his inhal.à~tiOn therapy treatment.
It has been proposed to use various check valves or pressure relief valves in a humidifier to avoid an excessive pressure buildup that might break tubing joints, etc. from their connections. When such a pressure relief valve does open to release pressure, it is importallt that the attending medical personnel be aware of it. This is so he can correct the obstruction causing the pressure buildup and quickly get the :~
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j patient back on his prescribed inhalation therayy. Previous inhalation therapy apparatus involved a spring biased check valve that exhausted released gas into a knife edge whistle such as a common toy whistle. However, the gas flow rates in a medical humidifier are sometimes too slow to cause a noise with such a whistle. Also, at very low pressures of beiween 2 and ~ psi above a~mospheric, these knife edge whistles do not always operate reliably.
U.S. patents nos. 4,061,698 and 4,100,235 disclose humidifier-nebulizer apparatus having an adapter head that includes control valve means movable to discharge a nebulized gas-liquid mixture from the adapter head during a nebulizing mode of operation and adjustable to introduce liquid oxygen into the reservoir in a manner to effect discharge of hl~iai~ied oxygen through a discharge port of the liquid reservoir of the apparatus.
; However, these apparatus do not include an audible relief valve ~eans which serves as an audible alar~ to indicate an above normal pressure in the humidifier to alert an attendant of his condition.
Sherman, U.S. patent no. 4,134,940, discloses a humidifier adapter comprising two oppositely facing, independently I movable, internally threaded pieces for connection to the gas ¦ conduit and the water bottIe, a body piece intermediate the two end pieces with an axial hose for holding a spike, a set screw transfixing the body piece, two pressure sealing "O" rings, ana an audible duck bill valve with retaining screw and flange upon which the valve sits. An internal pressure chamber is located between the spike and internal diameter of the body piece which connects with the water bottle, which body piece is transfixed by the duck bill valve.
~ ankel et al, U.S. patent no. 4,039,639, discloses a hu~idifier comprising a 1ap valve for emitting an audible alarm when excessive pressure exists in a nebulizer device. P. f1exible tube is used to connect an oxy~eo difuser immersed in liquid zolo7~z, J
to a source of oxysen.
.~,ePhee, ~.S. patent no. 3, B07, 445, discloses an audible pressure relief valve for ~ medical humi~fier. The ~7alve has a rubber disc that is dirnensionally tuned to vi}~rate a~ainst a valve seat and emit an audible soulld at sas flow rates OL 3 to 15 li~ers per minute and pressures of 1 to 5 psi above at-mospheric pressure.
Oliivier, ~.S. patent no. 3,867,934, discloses a pressure monitor for use with a lung ven~ilator. The monitor is connected to a pneumatically-operated warning aevice which may be audible, visible, or both.
Adolphsen et al, U.S. patent no. 2,267,009, discloses an oxy~en inhaling assembly including a tube for oxygen flow.
If the tube becomes clogged, pressure will build up in a casing and a diaphragm csnnected to the casing will begin to lift, releasing gas from the casiny for passage t~ough a duct to the atmosphere. In this case, the diaphrasm will vihrate, ~mitting a sound similar to that of an air h~rn.
The disadvantage of some of the prior art arrangements typified, for instance, by U~S. Patent 3,807,445 or U.S. Patent 4,039,63~ referred to above is in that the gas passing through the audible signal generating valve is moist. This gives rise to difficulties in calibrating the audible signal gen~rating valve with reasonable accuracy~ From this standpoint, it is of greater advantage to use the incoming oxygen before it passes through the liquid within the bottle. A typical example of this arrangement is seen in U.S. Patent 4,134,940 referred to above. The drawback of the latter arrangement, however, is in a considerable complexity of the structure of the valve. For instance, the piercing member passes through the entire body of the adapter and requires at least two sealing elements, usually O-rings at Pach end. It is furthermore necessary to provide the _ , _ B

~o~ z piercing member with passages directing pressurized oxygen to the relief valve. Since the piercing member is normally threadably received within the body portion of the adapter, it cannot be predic~ed as to which position the passages in the wall of the piercing mémber will assume.
Thus, it is necessary to provide a small diameter portion in the piercing member to secure a free annular space communicating the side port means of the piercing m~mber with the audible signal generating valve.
Thus, while securing the operation with dry oxygen which is desirable from the standpoint of the relief valve, the complexity of the Sherman arrangement makes the device too difficult to produce and also gives rise to potential difficulties with -respect to maintaing the equipment sterile.

SU~MARY OF THE_I VENTION

It is an object of the present invention to provide an adapter of the general type as shown in the Sherman paten~ which would combine structural simplicity with the possibility of obtaining a relatively exact calibration of the relief valve.
In general terms, the present invention provides an adapter for mounting on an engageable portion of a container over a pierceable seal thereon sealing therein a supply of purified or sterile water, and to be connected to a pressurized gas tube for introducing gas into the supply of water to moisten the gas, and adapter comprising two oppositely facing cups, an upper cup for connection to a gas conduit, a lower cup for connection to a container;
a generally cylindric body piece opera~ively engaged by said lower cup and including a normally lower face with a spike member protruding from said normally lower face coaxially with the cylindric shape of he body, said spike -3(a)-e~

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member being integral with the body piece; an axial bore extending through said body piece from a normally upper end thereof to the tip of said spike member to provide a passage through the body piece, an upper section of said axial bore being of an enlarged diameter and being provided with a thread at the normally upper end of ~he body piece; a sealing pin member having a passage therethrough and operatively engaged by the upper cup and threadably and sealingly engaging said bore at said normally upper end of the body piece, the passage in the pin and in the body piece being generally coaxial with each other; relief means in the body piece establishing communication between the passage and the outside atmosphere, said relief means being located at a point downstream of a normally lower end of said sealing pin; audible relief valve means adapted to effect audible pressure relief of the passage under above normal conditions.

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D escr_pt:ion_of t]~le Drawi~ys Fig.1 is a front view of the adapter o~ the present invention shown attached to a pre-filled ~iater bottle.
Fig. 2 is an end view and a cross-sectional view taken along line 3-3 o~ Fig.l showing the flow~eter connector end view of the adapter of the present invention.
Fig. 3 is a longitudinal cross-sectional view of the adapter of the pxesent invention attached to a pre--filled water bottle and to a gas conduit.
Fig. 4 is a cross-sectional view of the cross T of the adapter showing the cross T, the duckbill valve, and the retainer.¦
Referring to the drawings, and particularly to Fig. 1, the adapter¦
according to the present invention is shown at 10. The adapter is generally of cyli*drical shape, havlng a lowercup 11 of larger diameter than the body piece 13 and upper cup 12. A generally coaxlal bore 36 is provided lnternally of the adapter and extends the entire length of the body of the adapter. Lower cup 11 is ~1~ lnternally threaded for connection to a respirator bottle or liquid container or reservoir 16. The bottle 16 is constructed to contain a quantity of purified or sterile liquid, such as water, and has provision for mountlng the adapter 10 thereon.
In operatlon, the adapter 10 ls connected at upper cup 12 to a flowmeter tnot shownl which in turn is connected to a source of oxygen, alr, or the like (not shown). Upper cup 12 is internally threaded.
The body piece 13, intermediate the ~pper cup and the lower cup, contains a duckbill valve 15 within a retainer 27 which holds the duckbill valve in place. The body piece 13 also holds a set screw or seal~:ng pin, shown at 14. Attached to the body piece 13 is a chain 17 with a snap clip retaining ring 18 to iacilitate connection of the adapter to a pipe (shown in dotted lines) between uses.

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~2 Fig. 2 shows a horizontal cross-section of the adapter 10 taken along line 3--3. The hole't~h~ough sealing pin member 19 is shown at 35, ~e rë~ainer for t~e duckbill valve at 27, and the retaining chain at L7.
Fig. 3 shows a longitudinal cross-section of adapter 10 in place upon bottle 16. The bottle, or liquid reser~oir, generally is for~ed of blow-molded polyethylene and is sealed by a pierceable membrane. To connect the adapter to the bottle, the lower cup 11 of t~e adapter is screwed over the top of the bottle 16 ~y means of the internal threads in t~e lower cup 11.
Annular scoring member 22, located at the bottom of body piece 13, scores the top of the membrane on the ~ottle 16 to produce a tight seal between the bottle'and the adapter.

I The adapter 10 is provided with sealing pin member 19 in a seated, snug relation longitudinally of the entire adapter.
The sealing pin member 19 includes a generally tubular body 40 and sealing head 41. The sealing head 41 is adapted to mate with, for example, a seal in a flowmeter (not shown). The sealing pin member 19 centrally terminates in a cross T 24 with'hcles 30 on either side of the stem of the cross T to allow escape of built-up gas. Shoulders 26 of the cross T 24 ho3d the duckbill valve 15 in place. A retainer 27 is screwed into female threads 28 on the cross T to hold the duckbill valve 15 in places.
Notches 29 on the retainer 27 enable the retainer to be screwed on with a screwdriver. "O" rings 20 assist in providing a tight seal of the adapter. The "0" ring shown at 20 is loca,ed in a ring yroove 47 in the mid portion of the sealing pin member 19.
The ring groove ~7 may be made in any suitable manner in accordance with generally kno~n machin;ng principles. Set screw 14 on the body piece 13 is provided so as to be tightenable against thread 31 of the adapter to prevent unwanted rotation of the sealing pin member 19 after it is properly seated.

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The sea]ing pin mc-mber 19 includes at least t~/o stepped ¦ ;
d~meter portions. As illustra-ted in ~'ig. 3, a large diameter portion 45 of the tubular body extends through the upper cup 12 and the body piece 13, and a small diameter through the spike end portion 46 e~tends through the lower cup 11 of -the adapter.
Fig. 4 is a cross-section of cross T 24 showing holes 30 on either side O.L the stem of the cross-T allowiny escape of built-up gas. Duckbill Yalve 15 surrounds the cross T, and the retainer 27 surrounds the duckbill valve.
The tubular body 40 of the sealing pin member defines a longitudinal internal passage which may be in the form of a constant-diameter bore. This passage serves as a conduit for the pressurized gas through the adapter 10 to allow the gas to pass through the bottle 16 for moistening before discharge into a cannula.
In order to relieve excess pressure in the adapter, the spi~e member 13 is provided with a cross T 24 which communicates with the longitudinal internal passage of the spike member. The cross T defines an internal passage 48 at right angle to the longitudinal internal passage of the spike member and establishes communication between the longitudinal internal passage and the internal passage of the cross ~. Two openings or port means 30 on the cross T establish communication between the internal passage of the cross T and the outside atmosphere.
When the duckbill valve 15 is mounted on the cross T, air escaping from the openings 30 will activate the duckbill valve.
The two opposing tapered sides or valve portions 49 and 50 of the duckbill valve are flexible and vibratable aod converge to an apex where tne two sides define a slit 52 between them.
Normally this slit is closed as the two opposing sides lie flat against each other at the apex. When there is gas pressure, ho~ever, these portions separate and allow a gas discharge 1l 1 lZO~ ,~2Z

through the slit. 'rhese wall portions are adapted to vib~ate and produce an audible signal when gas flows bet~een thP~.
The adpater of the present invention is reusa~le and permanent. The adapter is preferably metallic an~ i~s ~ade, for example, by machining suitable ~laterial, such as ~rass. All such brass parts are then prerera~ly covered with a chrome plate or suitable stainless steel. The set scre~ 14 may be stainless steel. The "O" ring and the duckbill ~alye are preferably made from a silicone rubber having the ability to withstand temperatures normally experienced in a steam autoclave, such as 25~F to 275F, for thirty minutes. Preferably, the materlal Will withstand temperatures of 400F or more. An example of such material is a 45 durometer methyl-vinyl siloxane polymer proceesed for use in external medical equipment. This construction allows the adapter 10 to be sterilized as needed.
In operation, the adapter 10 as described herein will be used as part of respiratory apparatus to humidify a gas in inhalation therapy If pressure rises above nor~al in the ~1 respirator bottle or liquid reservoir 16, for any reason, the adapter 10 will ser~e as an audible alarm ta attract the attention of an attendant who can inspect the apparatus and remove the cause of the high pressure. If -the pressure in the respirator bottle is high as a result of high pressure from the gas source, globules of water may form and exit the humidiFier apparatus, and enter the lungs of the patient. On the other hand, if high pressure in the respirator bottle results from an occlusion in the outgoing line, such as by pinching of the line, humidifiea gas may not reach the lungs al all. In either situation, the result is a malfunction and an attendant should make an appropriate remedial adjustment.

Accordingly, gas flow exceeding a predetermined pressure is audibly vented to the atmosphere through the duckbill 0~2 valve 15. In a device constructed in accordance with the illustrated embodiment, the audio range has been Eound to be effective from about 0.07 cfm to about 0.5 cfm.
One adapter has been constructed in which the aaapter body is approximately two inches long and has a hose portion of approximately 0.40 inch. 'rhe large bore diameter portion of the spike member 13 has a diameter of approximately 0.125 inch. The material for the adapter body and the spike m.ember is chrome plated brass. The set screw 14 is a socket type screw made of stainless steel. The duckbill valve is made of rubber having the same characteristics described earlier in connection with the O-ring.
Generally, the gas flow through the adapter 10 and the bottle 16 to the patient ranges from approximately two liters per minute to approximately fifteen liters per minute, i.e., from about 0.07 cfm to about 0.53 cfm. In the aforesaid ~construction, an internal- pressure build of 3 to 3.5 psig will cause an outward flow of about 0.007 cfm through the duckbill valve 15. Sucn pressure buildup might result, for example, from a kink or other obstruction in the cannula leading to the patient.
In accordance with this invention, thè duckbill valve 15 is effective to respond to such low gas flow of about 0.07 cfm by an audible vibration of the opposing wall portions 49 and 50.
This audible vibration of these opposing walls continues until the flow of ~as outwardly of the duckbill valve exceeds about 0.5 cfm. In terms of liters per minute, this means that the valve audibly vibrates at gas flow rates therethrough withln a range of from two to fifteen liters per minute. At gas flow rates eY.ceeding fifteen liters per minute, the opposing wall portions 49 and 50 remain separated without audibly vibrating as the gas flows therebetween. The flow of fifteen liters per minute (about 0.53 cf~ at the upper end of the audible range ~2q~722 results from a pressure in the respirator bott~e 16 of a~out 6.5 psi~.
Thus, audible vibrations are produced in the duckbill valve 1~ at internal pressures of 3 to 6.5 psig at gas flow rates ¦
of two to fifteen liters per ~inute. An audible signal will be provided to alert an attendant to the fault conditions so that corrective action can be taken and the patient can again receive moistened gas from the system.
In s~mmary, there has- been disclosed a permanent hu~idifier adapter 10 for mounting on an engageable portion of a container or liquid reservoir 16 over a pierceable sealed surface of the container. A supply of purified or sterile water is sealed in the container. The adaprer also connects~a pressurized gas tube to the container for introducing gas with the supply of water to moisten or humidify the gas. The adapter 13 includes an upper cup means 12, a body piece 13, ana a lower cup means 11, the lower cup 11 having means at one end for engagin~ the container, and a bore axially extending through the adapter. A spike member 13 is pro~lided and inserted within the adapter. The spike member has a generally tubular body. A cross T
24 establishes communication~between the inside passage of the spike member through which,gas enters the container, and the , outside atrnosphere. An audible relief valve means including a duckbill valve is located on the''cross, T, whi'ch valve means effects audible pressure relief of the adapter under normal pressure chamber under above normal pressure conditions. The illustrated audible relief valve means has an e~fective audible range from the minimum flow that establishes sound to approxirnately eight times such minimum flow.
Although the invention has been described in connection with a preferred embodi3nent, alternatives, modifications, and variations may be apparent to those skilled in the art of the il foregoiny description. Accordingly, it is intended to e~bxace all such alternatives, modifications, and variations as fall within the spirit and scope of the ap~ended ~l~.ims.

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Claims (3)

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. A permanent adapter for mounting on an engageable portion of a container over a pierceable seal thereon sealing therein a supply of purified or sterile water, and to be connected to a pressurized gas tube for introducing gas into the supply of water to moisten the gas, the adapter comprising:
(a) two oppositely facing cups, an upper cup for connection to a gas conduit, a lower cup for connection to a container;
(b) a generally cylindric body piece operatively engaged by said lower cup and including a normally lower face with a spike member protruding from said normally lower face coaxially with the cylindric shape of the body, said spike member being integral with the body piece;
(c) an axial bore extending through said body piece from a normally upper end thereof to the tip of said spike member to provide a passage through the body piece, an upper section of said axial bore being of an enlarged diameter and being provided with a thread at the normally upper end of the body piece;
(d) a sealing pin member having a passage therethrough and operatively engaged by the upper cup and threadably and sealingly engaging said bore at said normally upper end of the body piece, the passage in the pin and in the body piece being generally coaxial with each other;
(e) relief means in the body piece establishing communication between the passage and the outside atmosphere, said relief means being located at a point downstream of a normally lower end of said sealing pin;
(f) audible relief valve means adapted to effect audible pressure relief of the passage under above normal conditions.

2. An adapter as claimed in claim 1, wherein the audible relief valve means is a dukbill type valve made of silicone rubber capable of withstanding temperatures normally experienced in a steam autoclave and having an audio range effective with gas flows therethrough of from 2 to 15 litres per minute.

3. An adapter as claimed in claim 1 or claim 2, further comprising a retaining ring disposed between a normally upper face of said body piece and a normally downwardly directed face of said upper cup, the inside diameter of said ring being greater than the outer diameter of a generally cylindric portion of the sealing pin member extending between the said upper cup and the body piece, but smaller than the outer diameter of the upper cup and of the body piece, whereby the ring is freely movable about the said generally cylindric portion but is axially restrained by the cup and by the body piece.