U.S. patent number 3,640,277 [Application Number 04/782,399] was granted by the patent office on 1972-02-08 for medical liquid administration device.
Invention is credited to Marvin Adelberg.
United States Patent |
3,640,277 |
Adelberg |
February 8, 1972 |
MEDICAL LIQUID ADMINISTRATION DEVICE
Abstract
Positive pressure apparatus for providing an adjustable and
reliably constant delivery rate of medical liquids from parenteral
applicators, including a self-contained portable medical liquid
administration device wherein precisely regulated gas flow through
a first flow restrictor operates to pressurize and cause to flow at
a substantially constant rate a liquid from a supply through a
second flow restrictor which has a flow/pressure drop
characteristic such that the liquid flow is essentially independent
of gravity-induced pressure fluctuations.
Inventors: |
Adelberg; Marvin (Sherman Oaks,
CA) |
Family
ID: |
25125928 |
Appl.
No.: |
04/782,399 |
Filed: |
December 9, 1968 |
Current U.S.
Class: |
604/141;
128/DIG.12; 222/61; 222/399; 73/861.71; 138/45; 222/386.5;
604/118 |
Current CPC
Class: |
A61M
5/1483 (20130101); A61M 5/16886 (20130101); Y10S
128/12 (20130101) |
Current International
Class: |
A61M
5/145 (20060101); A61M 5/168 (20060101); A61M
5/148 (20060101); A61m 005/00 () |
Field of
Search: |
;222/94,95,61,386.5,399
;128/214,214.2,215,216,DIG.12,225 ;138/45 ;91/31 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Claims
I claim:
1. In parenteral liquid administration apparatus, the combination
comprising:
a. container means having a first zone to receive a pressurized
first fluid and a second zone for a supply of a deliverable second
fluid, said zones extending in such confined and
pressure-transmitting relation that the second fluid remains
pressurized by the first fluid as the second fluid zone diminishes
and the first fluid zone expands;
b. means to deliver said first fluid to said first zone and
including a fluid pressure regulator and variable flow restrictor
means connected in fluid-flow-transmitting relation between said
regulator and said first zone; said flow restrictor means having
selector means for providing a predetermined but variable pressure
drop/flow rate characteristic; and
c. a conduit for delivering said second fluid for administration to
a patient from said second zone.
2. In parenteral liquid administration apparatus, the combination
comprising:
a. container means having a first zone to receive a pressurized
first fluid and a second zone for a supply of a deliverable second
fluid, said zones extending in such confined and
pressure-transmitting relation that the second fluid remains
pressurized by the first fluid as the second fluid zone diminishes
and the first fluid zone expands;
b. means to deliver said first fluid to said first zone and
including a fluid pressure regulator and flow restrictor means
connected in fluid-flow-transmitting relation between said
regulator and said first zone;
c. a conduit for delivering said second fluid for administration to
a patient from said second zone; and
d. means for selectively bypassing said flow restrictor means.
3. The combination of claim 1 wherein said container means
comprises first and second collapsible containers respectively
defining said first and said second zones and having a
pressure-transmitting and movable interface between said zones.
4. The combination of claim 3 including means confining said
container means in said pressure-transmitting relation whereby said
interface is movable relative to said confining means in response
to fluid flow from the second container during collapse
thereof.
5. The combination of claim 4 including an indicator having
operative connection to said interface to move therewith.
6. The combination of claim 1 wherein said first fluid delivery
means includes a liquefied gas container having an outlet in
communication with said pressure regulator.
7. The combination of claim 6 including liquefied CO.sub.2 in said
liquefied gas container.
8. The combination of claim 1 wherein said flow restrictor means
includes multiple restrictors mounted for selective connection in
said fluid-flow-transmitting relation.
9. The combination of claim 8 wherein each of said multiple
restrictors comprises a porous plug.
10. In parenteral liquid administration apparatus, the combination
comprising:
a. container means having a first zone to receive a pressurized
first fluid and a second zone for a supply of a deliverable second
fluid, said zones extending in such confined and
pressure-transmitting relation that the second fluid remains
pressurized by the first fluid as the second fluid zone diminishes
and the first fluid zone expands;
b. means to deliver said first fluid to said first zone and
including a pressure regulator and first variable flow restrictor
means connected in flow-transmitting relation between said
regulator and said first zone; said flow restrictor means having
selector means for providing a predetermined but variable pressure
drop/flow rate characteristic; and
c. means to deliver said second fluid for administration to a
patient from said second zone and including a conduit and a second
flow restrictor means connected in flow-transmitting relation with
said conduit;
d. said restrictors characterized in that the first fluid pressure
drop across said first restrictor means substantially exceeds the
second fluid pressure drop across said second restrictor means
whereby the second fluid flow rate in said conduit is maintained
substantially uniform and independent of normal gravity induced
pressure fluctuations.
11. In parenteral liquid administration apparatus, the combination
comprising:
a. container means having a first zone to receive a pressurized
first fluid and a second zone for a supply of a deliverable second
fluid, said zones extending in such confined and
pressure-transmitting relation that the second fluid remains
pressurized by the first fluid as the second fluid zone diminishes
and the first fluid zone expands;
b. means to deliver said first fluid to said first zone and
including a pressure regulator and first flow restrictor means
connected in flow-transmitting relation between said regulator and
said first zone;
c. means to deliver said second fluid for administration to a
patient from said second zone and including a conduit and a second
flow restrictor means connected in flow-transmitting relation with
said conduit;
d. said restrictors characterized in that the first fluid pressure
drop across said first restrictor means substantially exceeds the
second fluid pressure drop across said second restrictor means
whereby the second fluid flow rate in said conduit is maintained
substantially uniform and independent of normal gravity induced
pressure fluctuations; and
e. means for selectively bypassing said second flow restrictor
means.
12. The combination of claim 10 wherein said container means
comprises first and second collapsible containers respectively
defining said first and second zones and having a
pressure-transmitting and movable interface between said zones.
13. The combination of claim 12 including means confining said
containers in said pressure-transmitting relation whereby said
interface is movable relative to said confining means in response
to fluid flow from the second container during collapse
thereof.
14. The combination of claim 13 including an indicator having
operative connection to said interface to move therewith.
15. The combination of claim 10 wherein said flow restrictor means
includes multiple restrictors mounted for selective connection in
said gas-flow-transmitting relation.
16. The combination of claim 15 wherein each of said multiple
restrictors comprises a porous plug.
17. The combination of claim 10 including a bypass connectable
between said regulator and said first zone and including other flow
restrictor means of lower flow resistance than said first flow
restrictor means in series with said bypass and characterized that
said first fluid is rapidly flowable to said first zone to
pressurize same to a level substantially equal to the pressure
normally at the outlet side of said first flow restrictor means
when said bypass is not connected.
18. The combination of claim 17 wherein said other flow restrictor
means includes third flow restrictor means and fourth flow
restrictor means in series, said first zone being connected in
flow-transmitting relation to a point between said third and fourth
flow restrictor means with said third restrictor means being in
parallel with said first restrictor means, the ratio of the flow
resistance of said first flow restrictor means to said third flow
restrictor means being the same as the ratio of the flow resistance
of said second restrictor means to said fourth restrictor
means.
19. The combination of claim 17 including valve means to
selectively connect said bypass between said regulator and said
first zone.
20. The combination of claim 10 wherein said second restrictor
means comprises a porous plug.
21. The combination of claim 4 wherein said collapsible container
confining means comprises a housing having interconnected sections
that are relatively separable to permit replacement of said second
container, said conduit extending from said second container to
move therewith during collapse thereof, and the housing wall
containing an opening to pass said conduit and permit said movement
thereof.
22. The combination of claim 21 wherein said opening is at one end
of the housing, and said pressure regulator and said restrictor
means are at one side of the housing and enclosed therein.
23. The combination of claim 21 wherein said restrictor means and
said pressure regulator are contained within said housing, and said
housing sections have hinge interconnection.
24. The combination of claim 1 and further including flow-sensing
means for indicating fluid flow within the apparatus.
25. The combination of claim 24 wherein said sensing means is
located within said conduit.
26. A combination as set forth in claim 2, including
pressure-responsive means for inhibiting said means for selectively
bypassing said flow restrictor means when the pressure at said
first zone exceeds a predetermined value.
27. A combination as set forth in claim 3, wherein said container
means comprise a flexible bag.
28. The combination of claim 10 wherein said second flow restrictor
means is connected to be removable from said flow-transmitting
relation.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention is concerned with improvements in the administration
of medical liquids to patients' veins, arteries, and other portions
of the body. More particularly the invention provides a device for
such administration which is essentially independent of gravity and
also assures a uniform flow rate.
2. Prior Art
The administration of medical liquids is largely carried out by
gravity-induced hydrostatic pressure infusion of the liquid from a
bottle or other container suspended above the recipient an
acceptable distance. The flow rate is not easily controlled since
variations in relative positions of the receiving portion of the
patient and the dispensing bottle may occur with time as the
patient or bottle may be shifted about.
Moreover, previously available pressure-assisted administration
devices for carrying out intravenous infusions are quite
complicated and, when employed, relatively expensive. Previous
devices have lacked portability and simplicity. Thus, should a
patient require relocation such as from an operating to a recovery
room, or from a field emergency unit to a permanent hospital,
special, costly and awkward means such as an additional attendant
are required. In other cases, such as for cardiac or infant
patients, the desired flow rate must prescribed accurately
controlled or even deliberately changed from one prescribed rate to
another.
In previously known pressurized delivery devices, various sources
of pressure including gas and liquid have been used to pressurize a
supply of medical liquid to be administered. For example in U.S.
Pat. No. 3,044,663 to Norton et al. an auxiliary pressure supply
means such as a pump, air pressure tank or gas cartridge is
disclosed to be useful in displacing liquid from a container.
Similarly, in U.S. Pat. No. 2,842,123 to Rundhaug a collapsible
liquid supply is pressurized for subsequent delivery of liquid. In
these devices provision for control of flow of the administered
liquid is either absent, as in Norton, or operator adjusted as in
Rundhaug, either of which can result in unpredictable flow rate
conditions depending on the reliability of the pressure supply
and/or the skill and attention of the operator.
SUMMARY OF THE INVENTION
It is a major objective of this invention to provide for positive,
gravity independent control to a medical fluid delivery system in
which a selected flow rate is provided and maintained at all
times.
Briefly, and in general terms, the present invention provides, in a
medical liquid administration system, means for providing a first
fluid at a regulated, constant flow rate to selectively, reliably,
and accurately displace a second fluid and cause the second fluid
to also flow at a substantially constant flow rate. The invention
may also include means for minimizing the effects of
gravity-induced hydrostatic pressure upon flow of the second fluid,
and may further include means for filtering the second fluid during
pressurized flow. One feature of the present invention relates to a
new and improved structural assembly incorporating a container for
the second fluid together with combined means for filtering the
fluid and minimizing fluid flow due to normally encountered levels
of gravity-induced hydrostatic pressure.
Accordingly the invention provides a medical fluid administration
device which includes a supply of medical liquid and fluid passage
mans for connecting the liquid supply to a recipient. A
flow-restricting means is provided within the passage having a
fixed-flow channel constructed to pass little liquid under only
gravity-induced hydrostatic pressure, but to pass the desired
liquid flow rate at higher driving pressure. Means is further
provided for selectively pressurizing the liquid supply by
selecting the particular flow-restricting means through which the
driving fluid flows for controlled administering of the driven
liquid to the recipient.
The medical (second) liquid may be carried in a
pressure-collapsible container for displacement by a compressed gas
(first liquid) operating thereon for pressure displacing of the
second liquid therefrom.
Thus there may be provided in accordance with the invention a
medical fluid administration device which includes a container for
medical liquid having a collapsible volume and a liquid outlet, and
connector means defining a liquid passageway from the container
outlet, the passageway terminating in or with an applicator. A flow
restrictor is mounted within the passageway, the restrictor having
a fixed-flow channel, to permit the desired flow of liquid when
subjected to a pressure exceeding that induced by gravity.
Pressurizing means is provided for contracting the volume of the
container to expel the liquid therefrom at a predetermined
pressure, including a controllably releasable high-pressure fluid
supply.
Valve means are provided for controlling pressure and flow rate of
the driving fluid, the latter preferably being achieved through use
of a porous plug in the passageway providing narrow and tortuous
flow paths of great effective length relative to the axial flow
path through the plug. A plurality of such plugs may be provided,
each providing a different effective flow rate/pressure drop
characteristic and mounted for alternate registration with the
driving fluid passageway. Further features include quick-fill means
for rapidly pressurizing the container at the desired pressure
level.
The pressurizing means may further include a variable-volume
driving fluid receiver in pressure transmitting contact with the
driven or second fluid container which cooperates with contracting
means to contract the second fluid container upon a corresponding
increase in the volume of the driving fluid receiver. The
contracting means may take the form of inextensible material
partially or totally circumscribing the volume of the second fluid
container and the first fluid receiver whereby an increase in
volume of the first fluid receiver decreases the volume of the
second fluid by a corresponding amount. The first fluid receiver
and second fluid container may be each formed separately of thin
inextensible plastic sheeting or be formed thereof with a common
wall. In either event a rigid frame may surround the receiver and
container to define their maximum combined volume and to protect
them from external disturbances.
Still other features include provision of means associated with the
driving fluid supply in a manner to meter predetermined amounts of
this fluid corresponding to a quantity of second fluid to be
displaced from the container and means for indicating occurrence of
flow in the second fluid passage means at a portion thereof which
is transparent. Such indicating means may also indicate flow
rate.
Currently desired micron-sized particle filtering of medical
liquids is easily accomplished by the present invention, because of
the higher pressures available, in a medical liquid administration
device in which the driven fluid flows from a supply thereof along
a passageway into a user, by provision of means for filtering
minute foreign solid material from this fluid in the
passageway.
These and other objects and advantages of the invention, as well as
the details of illustrative embodiments, will be more fully
understood from the following description and drawings.
BRIEF DESCRIPTION OF DRAWINGS
FIG. 1 is a diagrammatic representation of a system incorporating
the invention;
FIG. 2 is a table illustrating pressure conditions in FIG. 1;
FIG. 3 is a graph of fill pressure versus time;
FIG. 4 shows one form of flow restrictor selector apparatus;
FIGS. 5-8 are sections illustrating various forms of gas and liquid
defining zones usable in the FIG. 1 system;
FIG. 5a is an end view of the FIG. 5 housing;
FIG. 9 is a perspective showing advantageous packaging of the
invention;
FIG. 10 is an end view of the FIG. 9 package;
FIG. 11 is an enlarged section taken through the flow restrictor
rotary selector of FIG. 9;
FIG. 12 is a section taken on line 12--12 of FIG. 11;
FIG. 13 is an enlarged section taken on line 13--13 of FIG. 9;
FIG. 14 is a section showing a flow indicator;
FIGS. 15a and 15b illustrate another flow indicator;
FIG. 16 is a section showing a modified indicator; and,
FIG. 17 is a section showing a check valve.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring first to FIG. 1, the illustrated system includes a
driving fluid contained in a pressure reservoir 10 the outlet of
which is connected at 11 to the inlet of a pressure regulator 12.
The reservoir 10 may for example consist of a small bottle of
two-phase (liquid-vapor) carbon dioxide or other high-pressure
fluid, as a source of driving energy. The pressure regulator 12
reduces the pressure of the driving fluid from a lever p.sub.1 to a
level p.sub.2, as indicated, and the latter may be varied within
limits by adjustment of the regulator control 13. Normally, p.sub.2
is much less than p.sub.1, as is stated in the FIG. 2 table of
preferred conditions.
The fluid at pressure p.sub.2, then flows via connection 14 to and
through a flow restrictor R.sub.1, FIG. 1 showing several of same
grouped at 15 and individually labeled at 15a, 15b, and 15c. Merely
for purposes of illustration, inlet valves are indicated at 16a,
16b and 16c as operable to control the flow to pass to and through
any of the restrictors. The latter permit different flow rates
corresponding to the pressure setting p.sub.2. Such flow rates may
vary over a wide range; and the design of the restrictors may be
made to accommodate that range as by varying the lengths or
cross-sectional areas, or both, of the restrictors as well as
choosing materials of different porosity. FIG. 4 shows three
restrictors 15a, 15b and 15c of different lengths in parallel
passages 17a, 17b and 17c formed in a block 18. A valve unit 20
having branches 21 and 22 is movable relative to the block to
selectively register passages 23 and 24 in those branches with the
passages 17a-17c. Preferably valve unit 20 is rotary, and one form
of rotary unit will be described subsequently.
As referred to, it is the purpose of the flow restrictors R.sub.1
to set the uniform rate of flow Q (usually very low) of the driving
fluid flowing at 33 to a zone 30 wherein contained pressure p.sub.3
is operable to drive fluid from a fluid zone 31 at uniform rate,
the rate Q being primarily determined by the pressure drop (p.sub.2
-p.sub.3) across the restrictor R.sub.1. Accordingly, there are
different rates of flow Qa, Qb and Qc for example, associated with
the different restrictors 15a, 15b and 15c. Intermediate flow rates
may be obtained by adjusting the control 13 on the pressure
regulator 12, which may for example adjust the spring tension in
the regulator. The latter may be of spring and diaphragm type, and
one example is that known commercially as Model 11-039,
manufactured by The Norgren Company of Littleton, Colo. The
regulator is such that p.sub.2 is maintained despite large changes
in p.sub.1, whereby the flow rate is kept uniform; however, the
sizes or capacities of reservoir 10 and zone 31 may be so related
that the reservoir exhausts just before zone 31 becomes exhausted,
providing automatic shutoff.
The flow restrictor or restrictors R.sub.1 may, for example,
consist of ceramic material or sintered metal, both of which are
porous. While needle valves could be used, they tend to be
contamination sensitive at low flow rates, and are not preferred.
Note also the use of safety valves 32 and 32a connected to lines 11
and 33 in FIG. 1. Valve 32 is opened to relieve remaining pressure
in reservoir 10, in response to opening of a container indicated at
34 containing fluid zone 31, in order to insure that the reservoir
10 cannot be reused without replacing with a full unit. Also,
reservoir 10 may take the form of a metal cartridge which may be
automatically disconnected from line 11 as by retractor 36 in
response to opening of the container 34. Safety valve 32a operates
to relieve pressure in line 33 should it inadvertently exceed a
preset level.
Reference to FIG. 5 shows that the preferred driving and driven
fluid zones are formed by separate and abutting collapsible
containers 40 and 41, respectively, having a large common
interface. These are housed within a rigid container or frame
having upper and lower sections 42 and 43. The upper section may be
removed to permit removal of an exhausted driven fluid container
and insertion of the new driven fluid container 41 over the driving
fluid container 40, which is typically, at such time, in a deflated
state or caused to be deflated by opening valve 32a. It then
becomes necessary to rapidly fill driving fluid into the deflated
container 40 so that normal flow of driven fluid from container 41
may be resumed or commenced. Such driven fluid flow passes via line
44 containing flow restrictor R.sub.2 to a tip 45 (such as a
needle) for delivery.
FIG. 1 illustrates a highly advantageous quick-fill system which
may be used to rapidly fill zone 30, i.e. container 40 in FIG. 5,
with driving fluid. As seen in FIG. 1, it includes flow restrictors
R.sub.3 and R.sub.4 connected in series at 46, restrictor R.sub.3
having its inlet connected at 47 to line 14 via a valve 48.
Similarly, line 46 is connected at 49 to the inlet to zone 30 via a
valve 50. Finally, the outlet of restrictor R.sub.4 is connected to
atmosphere. The flow resistance r.sub.3 of restrictor R.sub.3 is
made much less than r.sub.1 of a selected operating restrictor
R.sub.1, so that the driving fluid readily flows via lines 47, 46
and 49 to the zone 30 when valves 48 and 50 are open. Also, the
flow resistance r.sub.4 of restrictor R.sub.4 is so related to the
r.sub.2 of restrictor R.sub.2 that the following relationship is
established:
r.sub.4 /r.sub.2 =r.sub.3 /r.sub.1 (1)
Under these conditions, the pressure p.sub.3 will increase from a
value p.sub.0 to the operating value L in a short time t.sub.1, as
seen in FIG. 3.
When a particular restrictor R.sub.1 (15a-15c) is chosen to
establish the desired operating pressure p.sub.3, a corresponding
restrictor R.sub.3 (19a-19c, respectively,) is selected (as by
appropriate valving 180a-180c operatively connected to valving
16a-16c) to provide the proper flow resistance in accordance with
equation (1), so that the operating value L is rapidly
obtained.
FIGS. 6-8 show alternate forms of containers for the gas and liquid
zones 30 and 31. In FIG. 6, a single flexible container 52 contains
both zones separated by a common pressure transmitting wall 53, and
within a rigid frame or enclosure 54. In FIG. 7 the liquid zone 31
is formed by a flexible container 54a, and the gas zone 30 is
formed between that container and the rigid, fluid tight enclosure
55. In FIG. 8 both gas and liquid zones 30 and 31 are open to the
interior of container 56, with a gas-liquid interface at 56a.
Automatic shutoff is important to the latter to prevent unwanted
feeding of gas such as carbon dioxide to a patient upon exhausting
of liquid from zone 31. In all of these forms, the use of a rigid
outer housing or frame enclosing zones 30 and 31 is important to
prevent inadvertent squeezing of the containers (such as 40 and 41
in FIG. 5), i.e. pressurization of the zones. Also, the fixed shape
of the housing or frame defines limits of container pressurized
displacement to limit delivery of liquid to the outlet.
FIG. 1 also illustrates the provision of a gage to directly
indicate the relative displacement status of the zones 30 and 31.
Advantage is taken of the movement of interface 60 between the
zones to indicate such status, through use of a marker 61 driven by
that interface (say up and down) and adjacent to the calibration
indicia 62. FIG. 5a shows an application of this in the FIG. 5
embodiment, wherein the end wall of the case or housing is slotted
at 65 to pass the marker element 66 to the exterior from the
interior. The marker shank is held between the containers 40 and
41, as at interface 67, and there are calibration markings on the
housing to indicate the volume of fluid in the container 42.
Referring back to FIG. 1, the apparatus illustrated is well adapted
to use in administering parenteral or other solutions (as for
example intravenous infusions) to an animal or human patient, and
typically a needle 45 is employed for this purpose. In such event
R.sub.2 is constructed to provide a pressure drop (p.sub.5
-p.sub.4) sufficient in relation to gravity induced hydrostatic
head changes that might occur during administration that the latter
changes are not of critical significance as respects flow rate.
(Such flow rate may be correlated with pressure and indicated by
the gage 70 connected in line 14, and suitably calibrated.) On the
other hand, the pressure drop (p.sub.2 -p.sub.3) afforded by
restrictor R.sub.1 is much greater than the drop afforded by
R.sub.2. As a consequence, flow rate is primarily controlled by
R.sub.1, and only secondarily controlled by R.sub.2, but at the
same time R.sub.2 assures that the gravity induced hydrostatic head
fluctuations stemming from patient movement relative to the
apparatus of FIG. 1 and vice versa and will not affect the flow
rate to any significant degree. Also, R.sub.2 may be constructed to
provide filtering action to insure delivery of fluid free of
foreign particle contaminant. Such construction will be described
later. By way of example only, the hydrostatic head fluctuations at
the needle 45 would usually be less than one-half p.s.i., and the
pressure p.sub.4 would usually exceed 3 p.s.i.
Finally, FIG. 1 illustrates the use of a shutoff and check valve 71
near the needle 45. Further, a bypass line 72 containing a valve 73
is connected across the restrictor R.sub.2, for emergency use. The
bypass directs the flow in line 75 around R.sub.2. Alternately,
provisions may be made for the emergency complete removal of
restrictor R.sub.2.
FIG. 9 shows elements of another form of medical liquid
administration device as seen in FIG. 1. A container 100 formed of
flexible inelastic plastic sheeting material contains medical
liquid and overlies a gas receiving bag 102 also of plastic
construction. The container and bag are located within an enclosing
rigid frame or housing 103 having upper and lower sections 104 and
105. The latter are hinge connected at 106 for convenience in
insertion and removal of successive medical liquid containers 100,
and terminals 104a and 105a serve to hold them connected. The
container 100 has an outlet 101 at an end thereof for discharge of
the container contents. Outlet 101 is fluid tightly connected to
tubing 108 which terminates at its opposite end in an applicator
needle 120. Between the needle 120 (or other device such as a
catheter for administering fluids) and outlet 101, the tubing 108
is provided or bisected with a flow restrictor filter 122, the
construction and operation of which are described in detail
hereinafter, but which broadly has the function of obstructing
partially the passageway defined by tubing 108 to passage
therealong of liquids permitting desired flow rates only when
driving pressures are well in excess of those created by gravity
and thus cooperating with the pressurizing system to be now
described in providing controlled administration of medical
liquids.
The medical liquid-administering device herein is advantageously
portable, compact and self-contained. A pressurized driving fluid
supply meeting these requirements is contained in a cartridge in
which is stored liquefied CO.sub.2, fluorocarbons or hydrocarbons
contained under pressures required to maintain liquid-gas
equilibrium, or gases such as N.sub.2 under very high pressure.
While other sources of gas may be used herein, for maximum
operating convenience, universal commercial availability and
inherent portability, I prefer these cartridges. Note FIG. 9
illustrates use of such a cartridge 124 encased in a close-fitting
mounting holder 126. The holder is provided at its upper end with a
puncture tip conduit (not shown) adapted to receive, gastightly,
the outlet neck of the cartridge in the well known manner. Pressure
regulator 132, corresponding to that described at 12 in FIG. 1, is
located as shown in FIG. 9, to be enclosed along with holder 126
when cover section 104 is in the position seen in FIG. 10. Note
also the location of the pressure gage 128 (corresponding to gage
70 in FIG. 1) at one end of the package, as seen in FIG. 10. Gage
128 connects to conduit 130. Note also the bounding walls
180-183.
The control of the rate of flow of driving fluid, which rate is
determinative of the rate thereof entering driving fluid receiver
102 and thus the rate of displacement of medical driven fluid into
the recipient from container 100, is accomplished in conjunction
with the downstream driven fluid pressure (which is set by
appropriate adjustment of the pressure regulator 132) and also
independently of normal variations of the pressure downstream of
the flow rate control point. This is achieved by the use of the
flow limiting restrictor within a cylindrical body 140 having fixed
end segments 140a and a rotatable center 140b. These body segments
may be fastened at 138 and sealed with ring seals 141, as seen in
FIG. 11.
The flow rate restriction is obtained by passing the gas along
relatively narrow paths within the valve body 140 which tend to
impede gas flow. In the illustrated preferred embodiment, a porous
plug 142 in passage 144 is used as the gas-flow-restricting means,
such plug providing a multiplicity of narrow and tortuous paths for
gas flow whereby flow resistance is reliably controlled. Because
various rates of flow may be desirable for different operating
conditions, a plurality of driving fluid flow passages 144 may be
provided for plugs 142 of varying restrictive characteristics.
Thus, with reference to FIGS. 11 and 12 the center segment 140b of
the valve body is bored to have passages 144a, b, c and d
therethrough. Passages 144a, b, and c are each provided with a gas
flow restrictive porous plug 142 of different effective flow
rate/pressure drop characteristic e.g. through difference in
construction, diameter or, as illustrated, length of the plug
whereby different rates of gas flow may be had by rotation of the
center segment 140b around fastener 138 to index one or the other
of the passages to the single bore continuation of conduit 130 in
the end segments 140a.
A nonrestrictive flow passage 144d is provided as a bypass for
unrestricted gas flow to rapidly provide gas pressure e.g. at
startup of the device. In this regard, the quick fill bypass of
FIG. 12 does not appear in the FIG. 11 sectional view. To insure
against accident, separately actuable means are provided, best
shown in FIG. 12 for activating the quick fill. As there shown, the
valve body segment 140b is provided with a radial channel 146 in
which there is positioned a push pin 148 having an enlarged outer
end 148a for finger engagement and a reduced diameter inner end 150
axially slotted at 150a to move radially of the fastener 138 about
which the valve segment 140b rotates. Finger depression of the pin
148 against tension spring 152 aligns aperture 154 of the pin with
bypass passage 144d for quick fill gas flow. Inadvertent depression
of the pin 48 may be prevented by a suitable lock (not shown) which
may be gas pressure operated.
A further safety feature as seen in FIGS. 10 and 11 is found in the
provision of a relief valve 160 in conduit 131 which is set to
insure no greater than some predetermined pressure, this valve
corresponding to that seen at 32a in FIG. 1.
Having described the pressurizing means to include illustratively a
source of positive pressure such as and preferably a miniature
liquefied gas cylinder or cartridge, a pressure regulator and a gas
flow restrictor combination which operates independent of normal
variations of downstream gas pressure, reference is now made to
FIGS. 9 and 13 for the ensuing discussion of the driven fluid flow
restrictor aspect of the invention.
To remove operator error as a source of difficulty, the present
device employs a fixed-flow-channel-type restrictor. For this
purpose FIG. 13 illustrates a ceramic porous cylindrical plug 162,
which is the preferred form of flow restrictor 122. Other
flow-restricting devices including porous plugs formed of other
natural and/or synthetic materials, fused or bonded or otherwise
held in rigid configuration may be used. Membranous materials are
generally insufficiently strong to withstand the applied pressures
contemplated herein for satisfactory periods, but, if properly
supported, may be employed.
A highly advantageous aspect of the use of finely porous plugs or
similar type flow restrictor 122 is the opportunity to filter from
the to-be-administered fluid foreign matter which occasionally is
present therein. For this purpose channels 164 may have a size of
0.1 to 5 microns or more or less, these values being
illustrative.
Whatever the material of construction of flow restrictor 122, the
flow rate/pressure drop characteristic is desirably controlled for
particular effects. For example, flow restrictors intended to have
a filtering function may have a characteristic of less than 200
ml./hr./p.s.i., but this only by way of example. Every flow
restrictor, of course, will have a characteristic to reduce to
small degree the significance of gravity on flow of fluid to the
recipient.
Reference is now made to FIGS. 1 and 14 showing a flow indicator 79
in the form of a thin disc 80 in the path of liquid flow in the
line 75. The thin disc 80 includes a rigid stem 80a which is
connected to one end of an elastic or springlike filament 81, the
opposite end of which is suitably fixed in the line or tubing 75.
As flow increases, the thin disc moves downstream, due to the
elasticity or spring action as indicated by broken lines 82, and
can be seen when the tubing is transparent. Calibrated indicia 83,
mounted on and adjustable lengthwise of the tubing 75, may be
provided to afford flow rate information. Also, the downstream flow
line may be temporarily clamped to see if disc 80 snaps back, to
confirm the existence of flow. FIGS. 15a and 15b illustrate another
flow indicator in the form of a thin disc 85 having a rigid stem
85a secured to one end of an inelastic filament 86. As flow
commences, the disc 85 oscillates in the tubing, as between FIG.
15a and 15b positions, higher frequency indicating greater flow
rates. FIG. 16 shows a combination of the FIG. 14 and 15 concepts,
and wherein the disc element 80a stretches on spring element 81a to
show flow rate; and in addition the oscillator element 85a
oscillates on filament 86 (mounted on disc 80a) to confirm the
existence of flow. The thin disc elements 85 and 85a may take other
forms, e.g., small spheres, cylinders, grooved cylinders so long as
there is clearance between the tube and the element. Also, the
tubing containing the elements such as 85, 85a, 80 and 80a should
be circular and may consist of a short section of glass tubing.
FIG. 17 illustrates a type of check valve 90 that may be used in
line 75 near needle 45, to prevent back-flow. The valve has flaps
91 which spread to pass flow to the right, but close together to
block reverse flow.
It will be apparent that appropriate alarm devices (not shown) may
be utilized wherever system parameters are monitored, e.g. as at
70, 32a, 62 and 79 in FIG. 1, to indicate malfunctions, unsafe, or
undesirable conditions.
While particular forms of the invention have been illustrated and
described, various modifications can be made without departing from
the spirit and scope of the invention. Accordingly, it is not
intended that the invention be limited, except as by the appended
claims.
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