U.S. patent number 3,859,997 [Application Number 05/377,265] was granted by the patent office on 1975-01-14 for reservoir bag for anesthesiology.
This patent grant is currently assigned to Becton, Dickinson and Company. Invention is credited to William L. Douma, Robert A. Gandi.
United States Patent |
3,859,997 |
Douma , et al. |
January 14, 1975 |
RESERVOIR BAG FOR ANESTHESIOLOGY
Abstract
A thin walled bag formed of elastomeric or plastic material
having good tactile sensitivity has a neck with an opening formed
therethrough, said neck being stretched over a molded adaptor. The
adaptor has projections extending into the bag to prevent
obstruction of the neck opening when the bag is pulled to one
side.
Inventors: |
Douma; William L. (West
Patterson, NJ), Gandi; Robert A. (Greenwich Village,
NY) |
Assignee: |
Becton, Dickinson and Company
(Rutherford, NJ)
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Family
ID: |
26880772 |
Appl.
No.: |
05/377,265 |
Filed: |
July 9, 1973 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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185077 |
Sep 30, 1971 |
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Current U.S.
Class: |
128/205.17 |
Current CPC
Class: |
A61M
16/0078 (20130101) |
Current International
Class: |
A61M
16/00 (20060101); A61m 016/00 () |
Field of
Search: |
;128/188,191,202 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Disposable Plastic Breathing Bags & Tubes; Parmley et al.,
JAMA, 9/27/71..
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Dunne; G. F.
Attorney, Agent or Firm: Kane, Dalsimer, Kane, Sullivan and
Kurucz
Parent Case Text
This application is a continuation of application Ser. No. 185,077,
filed Sept. 30, 1971, now abandoned.
Claims
We claim:
1. A low cost disposable two-piece reservoir bag, comprising:
an integral single-piece thin walled, substantially uniform
thickness, a leak-proof bag of a flexible elastomeric rubber
material, the bag elasticity and thinness cooperating in rendering
the bag expandable under over-pressure conditions thereby avoiding
exposure to the patient of excessive pressures, the bag being of
low gas permeability and having a neck with an opening formed
therein in communication with the interior of the bag, the bag
having good tactile sensitivity and being conductive throughout all
surfaces thereof;
conductive adapter means fixedly positioned within the neck and
including a portion extending from said bag, the adapter having an
annular radial projection extending therefrom intermediate the ends
thereof, and the rubber neck being elastically stretched into
engagement with the adapter over the projection to thereby provide
a tight sealed interengagement between adapter and bag and to
provide a continuous conductive path from end to end of the
two-piece bag; and
projections formed on the adapter and extending into the interior
of the bag for preventing obstruction of the opening when the bag
is displaced to one side.
2. A disposable reservoir bag as described in claim 1, additionally
comprising retaining means for retaining the neck portion of the
bag around the adaptor means.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to anesthesiology systems and more
particularly to a disposable breathing or reservoir bag for an
anesthesiology system.
2. Description of the Prior Art
Heretofore, anesthesiology systems were equipped with reusable
reservoir bags which among other things served as a means by which
the anesthesiologist sensed the pressure changes produced by the
pateint during ventilation, thus sensing patient response to, and
stage of, anesthesia. There were two major requirements for a
practical reservoir bag. Firstly, the bag had to be formed of
electrically conductive material because some of the gases used
during anesthesia were of an explosive nature. Secondly, the bag
had to have good tactile sensitivity to allow the anesthesiologist
to sense the pressure changes transmitted by the patient's
respiratory efforts.
Because of these requirements, the reservoir bags were relatively
expensive to produce and therefore not considered disposable.
Consequently, the bags had to be cleaned and sterilized between
uses to minimize the possibility of cross contamination from one
patient to another. The sterilization procedures consumed
considerable time and required the use of equipment and personnel
which added greatly to overall operating cost.
Generally, the reservoir bags were flushed with antiseptic between
uses in an attempt to destroy harmful microorganisms, however, this
procedure proved to be only partially effective, and as a result,
many patients were subjected to possible cross infection with
microorganisms from other patients.
In an attempt to overcome this problem, one prior art device
utilized disposable liners within the bag that could be discarded
after each use to prevent contamination of the interior of the bag.
While this device greatly reduced the possible occurrence of cross
contamination, considerable time was required to insert and remove
the liners from the bags and the device proved to be
impractical.
There were attempts to provide a dip formed thin walled reservoir
bag; however, it was discovered that the neck portion of the thin
walled bag was weak and subject to tearing when the bag was being
connected to an anesthestic system. As a result, it was required
that the neck portion be dipped several times to form a thicker
wall; however, this greatly increased the cost of manufacture and
rendered the bag expensive and non-disposable.
In another attempt to provide a disposable reservoir bag, plastic
sheets were heat sealed together to form a bag. This bag was not
expandable and therefore no physical indication was provided when
an overpressure condition developed. Such a condition is
detrimental to a patient. The seams of this bag were subject to
rupture and leakage, and thus, the bag did not provide an
acceptable substitute for the previously used non-disposable
reservoir bags.
Another difficulty encountered with the bags of the prior art was
in the connection of the bags to the anesthetic system. There was a
tendency during use for the bag to be pushed or pulled to one side
of the anesthetic system, and as a result, the neck of the bag
would become obstructed isolating the bag from the remainder of the
anesthetic system. There was also a tendency for the bags having an
adaptor to accidentally slip from the adaptor resulting in escape
of anesthetic gases to the atmosphere.
SUMMARY OF THE INVENTION
The present invention contemplates a disposable breathing or
reservoir bag for use with an anesthetic system. The bag is formed
of an elastomeric material such as latex rubber or a plastic and is
formed by dipping a form into a latex solution and thereafter
curing the latex to make the bag which is then removed from the
form. This procedure provides a bag having a thin wall of uniform
thickness and good tactile sensitivity to assist the
anesthesiologist in determining the patient's lung compliance and
thus sensing the patient's response to, and stage of, anesthesia.
Since the bag is formed of an elastomeric material, the bag expands
under overpressure conditions thus relieving some of the pressure
that would be transmitted to the patient's lungs if a
non-expandable bag was used. This expansion also gives a physical
indication that the system is becoming overpressurized.
The bag is formed with a neck portion having an opening
therethrough which is stretched over a molded adaptor. The adaptor
has a generally cylindrical exterior surface with an outwardly
extending flange formed around the periphery at the midpoint
thereof. The neck of the bag is extended over and beyond the flange
where it is secured to the adaptor by the use of a heat shrinkable
band. The flange helps to secure the bag to the adaptor and
prevents inadvertent slippage of the bag from the adaptor. The
adaptor is formed so that it can be easily connected to and
detached from standard anesthetic systems without the need for
other special connectors.
A unique characteristic of the adaptor is that it has projections
that extend into the bag to prevent obstruction of the anesthetic
system when the bag is either pulled or pushed to one side of the
anesthetic system. In the prior art devices, if the bag were
inadvertently pushed to one side, the neck would obstruct causing
the bag to be isolated from the anesthetic system.
A most important characteristic of the reservoir bag, contemplated
by the present invention, is its low cost which is a result of the
method used in manufacture of the thin walled bag. Because of the
use of a molded adaptor, the neck of the bag may be of the same
thickness as the remainder of the bag because the adaptor provides
added strength for the neck portion. Since the bag may be of
uniform thickness, it may be formed by a single dipping operation
thereby eliminating the need for additional dippings. Thus, the
manufacturing operation is simplified and costs are greatly
reduced.
The reduced cost renders the bag disposable and also eliminates the
cost of sterilizing the bag between uses. In addition to the cost
savings resulting from this type of bag, the most important
advantage of this bag is that all possibility of cross
contamination resulting from the use of the same bag on more than
one patient is eliminated. This advantage alone makes the present
invention a substantial improvement over the bags of the prior
art.
The material from which the reservoir bag is made may be conductive
or non-conductive elastomer or plastic material. The conductive
material is required when the anesthetic agent used is an explosive
gas; however, the trend in some hospitals today is towards the use
of non-explosive anesthetic agents and in such cases a
non-conductive bag may be used. Non-conductive bags have many
advantages over the conductive type in that they may be produced at
a lower cost and they may also be made of transparent, translucent
or colored material rather than the black conductive type of
material presently required for conductive bags.
The main objective of the present invention is to provide a
reservoir bag that is disposable so that all possibility of cross
contamination caused by the reuse of reservoir bags will be
eliminated.
Another objective of the present invention is to provide a
reservoir bag that is less expensive than the bags heretofore
provided.
Another objective of the present invention is to provide a
disposable reservoir bag whereby the cost of sterilization between
uses is eliminated.
Another objective of the present invention is to provide a
reservoir bag that expands and increases in volume under
overpressure conditions.
Another objective of the present invention is to provide a
reservoir bag that has good tactile sensitivity.
Another objective of the present invention is to provide a
reservoir bag having an adaptor that prevents obstruction of the
bag opening when the bag is pushed to one side.
Another objective of the present invention is to provide a
reservoir bag that includes an adaptor to provide added strength in
the neck portion of the bag and to facilitate connection and
disconnection from an anesthetic system.
Another objective of the present invention is to provide a superior
connection between a reservoir bag and an adaptor.
The foregoing objectives and advantages of the invention will
appear more fully hereinafter from a consideration of the detailed
description which follows, taken together with the accompanying
drawings wherein twoo embodiments of the invention are illustrated
by way of example. It is to be expressly understood, however, that
the drawings are for illustrative purposes only and are not to be
considered as defining the limits of the invention.
DESCRIPTION OF THE DRAWINGS
FIG. 1 is an assembly drawing of a bag constructed in accordance
with the present invention.
FIG. 2 is a drawing showing the assembled bag of FIG. 1.
FIG. 3 is a partial sectional view taken along line 3--3 of FIG.
2.
FIG. 4 is an end view of the adaptor taken along line 4--4 of FIG.
1.
FIG. 5 is a sectional view taken along line 5--5 of FIG. 1.
FIG. 6 is a sectional view corresponding to that of FIG. 5 of
another embodiment of the present invention.
DESCRIPTION OF THE INVENTION
Referring to FIG. 1, there is shown an assembly drawing of the
reservoir bag of the present invention. The reservoir bag comprises
a thin walled bag 11, an adaptor 13 and a band 15. The bag has a
neck portion 17 having an opening 19 formed therethrough. The bag
is thin walled having a thickness in the range of 0.010-0.025
inches and is formed by a dipping process. A form having an outer
surface configuration similar to the desired bag configuration is
dipped into a latex solution and then removed. The latex solution
adheres to the form after the form is retracted from the solution
and the latex is then cured forming a thin walled bag which is then
removed from the form.
Referring to FIG. 5, it may be seen that the bag has an H-shaped
cross section. There are many possible cross sections that may be
used in the practice of the present invention such as the X-shaped
cross section shown in FIG. 6. The H-shaped cross section is
preferred because it facilitates the removal of the bag from the
form. The neck portion 17 of the H-shaped bag need not be stretched
as much to remove the bag from the form as would be required to
remove the bag from an X-shaped form as shown in FIG. 6. This is
particularly significant when a conductive bag is being
manufactured because in such instances carbon particles are
distributed in the latex solution to render the solution conductive
and undue stretching of the cured latex may have an adverse affect
on the conductivity of the final product. Another advantage of the
H-shaped cross section is that it facilitates packaging of the bag
because the bag has a natural flat configuration.
A preferred bag capacity is 3 to 5 liters, and the bag must be of
sufficient strength to withstand a gauge pressure of at least 6 cm
of mercury without leakage or rupture.
When the bag is to be used for explosive anesthetics, carbon
particles are intermixed with the latex to form a conductive
material from which the bag is made. The maximum electrical
resistance of the bag must be 1 megohm or less. The conductivity,
provided by 1 megohm, is required so that static charges collected
on the surface of the bag may be conducted to ground to avoid
discharge by sparking and the possibility of igniting the explosive
anesthetic mixture.
If a non-conductive bag is desired for use with a non-explosive
anesthetic elastomeric or plastic material may be used without
carbon to form the bag. Since carbon is not required, the bag may
be made clear or any color.
While any elastomeric flexible material of low gas permeability may
be used to form the bag, latex rubber has good tactile sensitivity
and allows the anesthesiologist to sense the pressure changes
transmitted by the patient during ventilation.
The latex rubber is also elastomeric and allows the bag to expand
when an overpressure condition exists. This characteristic has two
advantages. Firstly, the expansion of the bag tends to reduce the
pressure to which the patient is exposed. Secondly, it provides a
physical warning to the anesthesiologist or other attendant that
the patient is being exposed to an overpressure condition.
Referring again to FIG. 1, it may be seen that bag 11 has a tip 21
formed at an end opposite the neck portion 17. The tip is formed so
that the bag may be connected in series in a different type of
anesthetic system. When a series connection is desired, the tip is
cut off and an adaptor inserted into that end of the bag so that
the bag has an inlet at one end and an outlet at the other end.
Adaptor 13 is molded from a conductive hard rubber or plastic
material. The adaptor has a cylindrical shape having an outside
diameter of approximately 1 5/32 inches and has a tapered opening
formed therethrough. The widest inside diameter of the opening is
approximately 0.863 inch and the taper is approximately 0.025 inch
diameter per 1 inch of length. An outwardly extending flange 23 is
formed about the periphery of the adaptor and has a circular
channel 25 formed therein. Three equally spaced projections are
formed on one end of the adaptor, the function of which will be
explained subsequently.
During assembly, the neck portion 17 of bag 11 is stretched over
adaptor 13 and flange 23 so that it extends to within approximately
one-fourth inch of end 29 of adaptor 13. The neck portion is then
released and because of its elastomeric characteristic, it conforms
to the outer shape of the adaptor.
Band 15 is formed of a heat shrinkable material such as clear
polyvinyl chloride having a thickness of approximately 0.0030
inches, a diameter of approximately 50 mm and a width of about
five-eighths inch. Band 15 is placed over adaptor 13 so that it
partially overlaps the adaptor and partially overlaps neck 17 of
bag 11. The band is then heated causing it to shrink and form a
secure connection between the neck 17 and adaptor 13. The band need
not be conductive because an electrical connection is made between
the bag and the adaptor and the adaptor itself is electrically
connected to the anesthetic system.
An alternate method of connecting neck 17 to adaptor 13 would be to
use an O-ring driven into channel 25 after neck 17 is placed over
the adaptor. The O-ring would then function to lock the neck in
place over the adaptor and prevent its inadvertent slipping from
the adaptor. Another method of connecting neck 17 to adaptor 13
would be to use a suitable bonding agent.
As can be seen most clearly in FIG. 3, the projections 27 of
adaptor 13 project through neck portion 17 and into bag 11. These
projections prevent obstruction of the neck and closure of its
opening when the bag is accidentally pushed or pulled to one
side.
Thus, the present invention provides an inexpensive, disposable
reservoir bag for an anesthetic system. The bag has an adaptor that
may be easily attached to and detached from the standard couplers
used on anesthetic systems. The bag is formedof an elastomeric
material and may be inexpensively manufactured from either a
conductive or a non-conductive material. The bag expands under
overpressure conditions which would otherwise be exerted directly
into the patient's lungs, and also provides a visible indication
that such a condition exists. The elastomeric material has a good
tactile sensitivity so that the anesthesiologist may sense changes
in the patient's lung compliance. A uniquely configured adaptor
prevents inadvertent obstruction of the neck portion of the bag and
also provides added strength to the neck so that the bag may be
formed with a uniform thickness thereby reducing the manufacturing
costs of the bag. The reduced cost renders the bag disposable and
eliminates the costly sterilization procedure required of other
reusable bags. The disposable characteristic of the bag taught by
the present invention makes possible the elimination of any
possibility of cross contamination of diseases between patients
caused by the bag. Thus, the present invention provides a bag for
an anesthesiology system that is less expensive and has many
advantages over the bags heretofore provided.
* * * * *