U.S. patent number 3,780,732 [Application Number 05/132,516] was granted by the patent office on 1973-12-25 for non-gravitational infusion set.
Invention is credited to Saul Leibinsoh.
United States Patent |
3,780,732 |
Leibinsoh |
December 25, 1973 |
NON-GRAVITATIONAL INFUSION SET
Abstract
A pressure-applying device for use in an infusion set for
feeding blood, saline solution or other fluids from a compressible
bag to a catheter or needle for administration to a patient. The
device comprises at least a pair of highly resilient, arcuate
shaped metallic plates pivoted along their adjacent edges and drawn
together along their free edges by buckles or clasps. When pivoted
into facing relation the adjacent convex surfaces of the plates act
to squeeze fluid from the compressible bag when positioned
therebetween. Use of the device obviates the necessity to elevate
the infusion bag during use, since infusion is effected by positive
pressure rather than by gravity alone.
Inventors: |
Leibinsoh; Saul (Rishon Lezion,
IL) |
Family
ID: |
26830434 |
Appl.
No.: |
05/132,516 |
Filed: |
April 8, 1971 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
753405 |
Aug 19, 1968 |
3595232 |
Jul 27, 1971 |
|
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Current U.S.
Class: |
604/134; 222/336;
128/DIG.12 |
Current CPC
Class: |
A61M
5/148 (20130101); Y10S 128/12 (20130101) |
Current International
Class: |
A61M
5/145 (20060101); A61M 5/148 (20060101); A61m
005/14 () |
Field of
Search: |
;128/214F,214R,DIG.12,DIG.15,DIG.20,402 ;222/95,97,102,336 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: McGowan; J. C.
Parent Case Text
BACKGROUND OF THE INVENTION
This application is a continuation-in-part of my application, Ser.
No. 753,405, filed Aug. 19, 1968, now U.S. Pat. No. 3,595,232
granted July 27, 1971, and is directed to an improved form of the
infusion device thereof.
Claims
What is claimed is:
1. An assembly for exerting pressure upon a compressible fluid
container, comprising:
a. a pair of curved resilient plates having respective inner and
outer planar edges extending transversely of the curvature
thereof;
b. hinge means for hingedly mounting said inner edges of the plates
to one another in substantial parallelism for pivotal movement of
the plates into facing relation with the convex surfaces of the
plates facing one another;
c. clasp means mounted along said outer edges of the plates for
securing said edges to one another and thereby holding the plates
in close proximity to one another with the convex surfaces thereof
adapted to apply pressure to a compressible fluid container
positioned between said plates;
d. restraining means for limiting movement of the compressible
fluid container transversely of said first and second plate edges
to facilitate compression of the container and dispensing of the
fluid therefrom by said assembly;
e. said restraining means comprises a hollow sleeve secured to said
sheath in the region of said hinge and along the concave side of
said plates for receiving a compressible fluid bag to prevent
movement of said bag when said plate halves are being moved to the
operating position.
2. The assembly of claim 1, wherein said restraining means further
comprises a plurality of hollow sleeves of different diameters
secured to said sheath in the region of said hinge and along the
concave side of said plates for receiving compressible fluid bags
of varying sizes, each of said sleeves preventing movement of the
bag received therein as said plate halves are moved to the
operating position.
Description
The present invention relates to infusion apparatus, and more
particularly to a novel sterile fluid infusion set of the
non-gravitational type which is adapted to provide positive fluid
flow for infusion, regardless of the relative positioning of the
infusion set with regard to the patient. The infusion set may be
provided with a drip chamber which prevents air from entering into
the flow of the exiting fluid even in cases where the orientation
of the drip chamber may become accidentally altered during use.
Infusion apparatus finds widespread use in the medical field. For
example, when it is desired to infuse blood or other sterile fluids
into the body of a patient being treated, the fluid to be
introduced into the body is typically fed from a suitable container
(e.g., of glass or plastic) supported a predetermined distance
above the patient's body, infusion being effected by gravity flow.
In military or other field applications when, for example, the
patient is carried on a stretcher an extra person is needed to hold
the infusion bottle or other container above the patient and thus
provide gravitational infusion of the fluid. In such situations,
which may occur during warfare, riots, or other disaster
conditions, it is extremely advantageous to permit infusion while
eliminating the necessity for a third person to carry the fluid
container.
One obvious technique for eliminating the noted problem involves
the provision of a structure mounted to the stretcher to support
the fluid container a predetermined height above the person being
carried. In most cases, this approach is either awkward or
impossible. It thereby becomes extremely important to provide
suitable alternative means for carrying out such infusion, while,
at the same time, eliminating the need for a third person to
accompany the stretcher bearers or eliminating the awkward support
assembly which must be secured to the stretcher.
SUMMARY OF THE INVENTION
The present invention is characterized by providing an infusion set
which may be readily and simply attached to a stretcher, or any
other support or surface, which need not be elevated above the
patient treated and, in fact, may be suspended a predetermined
distance below the patient or may simply be laid upon a hospital
bed or stretcher alongside the patient, and which, at the same
time, effects fluid infusion at a substantially controlled and
constant rate.
THe present invention comprises an assembly having at least first
and second arcuate shaped highly resilient members adapted to
receive a compressible fluid-containing bag between their convex
surfaces. The resilient members are covered by suitable heavy-duty
woven fabric sheets which further serve as pivoting means aligned
along a pair of adjacent edges of the arcuate shaped sheets. The
opposite free ends of the fabric sheets are provided with suitable
fastening means adapted to retain the arcuate sheets in close
proximity to one another so as to exert a large compressive force
upon the compressible fluid-containing bag positioned therebetween.
The force exerted upon the compressible bag by the arcuate shaped
resilient sheets is of significant magnitude as to enable and
provide for fluid flow of a sufficient magnitude, regardless of the
relative positioning between the infusion set and the body of the
patient receiving the sterile fluid, thereby enabling the bag to be
supported at a height which is the same as or even below that of
the patient, while still providing for adequate fluid flow from the
compressible bag to the patient, which flow may further be
controlled by valve and/or drip chamber means.
In accordance with a further feature of the invention, the
pressure-applying device includes restraining means for limiting or
preventing lateral movement of the fluid-containing bag during
compression thereof. Such means, which may comprise a sleeve for
receiving the infusion bag, a belt for winding about the bag, or
simply an adhesive surface for engaging the bag or the belt,
frictionally engages the infusion bag to prevent its expulsion
from, and maintain it within, the pressure-applying means during
compression thereof and thus facilitate substantially continuous
and uniform dispensing of the blood, saline solution or other
fluid.
The basic components of an infusion set include the fluid container
and a catheter or needle coupled thereto by suitable tubing. The
pressure-applying means of this invention is suitably employed in
combination with these components and, typically, a stopcock or
other valve means and a drip chamber for regulating the flow of the
fluid infused. Whereas infusion sets provided in accordance
herewith may incorporate conventional catheters, drip chambers and
stopcock elements, it is preferred that the drip chamber employed
be of the type described in my copending application entitled "Drip
Chamber For Infusion Set", Ser. No. 132,789, filed Apr. 7, 1971,
now U.S. Pat. No. 3,721,689.
The infusion set described hereinabove is especially adapted for
use in military applications and is ideally suited for battlefield
conditions. The compressive forces developed by the arcuate shaped
springy members assure continuous, uniform infusion and further act
to prevent cannula clogging and reverse flow. Upon appropriate
operation of the valve means controlling flow, the contents of an
infusion bag may be rapidly emptied. For example, 1000 ml. may be
infused through an 8 .times. 5 inch Fr. cannula within 10-12
minutes and through a 14 gallon needle in less than 5 minutes.
The compressive forces eliminate the need for a support normally
required for conventional gravity flow systems in that the
structure is capable of developing pressure equivalent to a head of
150 cc. In use, the structure permits easy transportation of
casualties - in battlefield conditions -- as well as in ambulances,
helicopters, planes or other air or ground vehicles. Obviously, the
versatility of the infusion set permits its use under normal
conditions such as exist in hospitals, clinics and the like. The
infusion set is adaptable for use with all commercially available
infusion bags (i.e., 400, 500 or 1000 ml.), is simple to use
requiring no instruments or tools of either special or general
purpose design, is quite durable and is capable of being applied in
an unlimited number of applications. The nature of the compressive
structure is such as to provide an extremely rugged, unbreakable
device having an indefinite shelf-life under any climatic
conditions, and having the further added feature of providing
excellent protection from an infusion bag which may be stored
therein, thus minimizing the risk of rupture or other damage, when,
for example, an infusion set incorporating the same is dropped by
parachute to a battlefield site or the like.
THE DRAWINGS
The preceding and other objects and advantages of the invention
will become apparent from the following description taken in
connection with the accompanying drawings in which:
FIG. 1a is a top plan view of an infusion apparatus embodying the
principles of the present invention;
FIG. 1b is an end view of the embodiment of FIG. 1a;
FIG. 1c is a bottom plan view of the embodiment of FIG. 1a;
FIG. 1d is a sectional view of a portion of the infusion apparatus
of FIG. 1c looking in the direction of arrows 1d--1d';
FIG. 1e is an end view of the embodiment of FIGS. 1a - 1c in the
closed (operating) position and containing a compressible fluid
bag;
FIG. 1f is an end view of the embodiment of FIGS. 1a - 1c in the
closed (storage) position;
FIGS. 2a and 2c are top and bottom plan view, respectively of
another, preferred embodiment of the present invention;
FIG. 2b is an end view of the embodiment of FIGS. 2a and 2c,
showing the infusion assembly in the open position preparatory to
use;
FIG. 2d is an end view of the embodiment of FIGS. 2a - 2c showing
the infusion assembly in the closed (operating) position and
containing a compressible fluid container;
FIG. 2e is a sectional view of a portion of the embodiment of FIG.
2c looking in the direction of arrows 2e -- 2e';
FIG. 2f is an end view of another preferred embodiment of the
present invention;
FIG. 3 is a plot showing curves useful in explaining the advantages
of the present invention as compared with conventional gravity-flow
techniques.
THE PREFERRED EMBODIMENTS
One preferred embodiment of the present invention is shown in FIGS.
2a - 2e. Turning initially to a consideration of FIGS. 2a - 2c, the
apparatus 100 shown therein is comprised of a pair of
arcuate-shaped members 101 and 102 which consist of first and
second arcuate-shaped metallic plates 103 and 104, shown best in
cross-sectional view of FIG. 2b. The plates, in addition to being
arcuate in shape, have a high degree of resiliency so as to retain
their arcuate configuration in the absence of any external forces.
Whereas the plates are described as being formed of metal, it
should be understood that the plates may also be formed of a
resilient plastic or other suitable material.
The plates 103 and 104 are covered on both surfaces thereof, as
well as along their perimeters, with a heavy duty fabric such as,
for example, a heavy canvas material. As shown best in FIG. 2b, one
continuous piece of fabric, comprised of top portions 105a and
105b, covers the convex surfaces of metallic sheets 103 and 104,
respectively. The concave surfaces are also covered by the single
sheet of fabric, whereby portions 106a and 106b are folded around
the edges of plates 103 and 104 to cover the concave surfaces of
sheets 103 and 104, respectively. The fabric sheets are joined to
one another along the remaining portions of the perimeter of each
of the metallic plates 103 and 104, preferably by being sewn
together.
Noting FIG. 2b, sheet portion 105a has its extreme left-hand edge
surrounding the left-hand edge 103a of plate 103. Lower sheet
portion 106a is bent inwardly upon itself, as shown at 106a', with
the two sheets being sewn together, as shown at 107. The fabric
sheet portions 105b and 106b are joined together about the
remaining perimeter of metallic sheet 104 in a similar fashion and
are sewn together along their engaging margins at the location
shown by the numeral 106b'. Sheets 105a and 105b terminate at the
center line of the structure designated by phantom line 108 and are
folded under, as shown at 105a' and 105b'. The metallic rivets 109
pierce these fabric sheet portions and metallic sheets and act to
firmly secure the heavy-duty fabric to the arcuate shaped metallic
sheets. The rivets 109 are shown best in the top view of FIG. 2a
which shows the convex surfaces and the bottom view of FIG. 2c
which shows the concave surfaces of the pair of arcuate assemblies
101 and 102.
Assemblies 101 and 102 are of equal length and have their free ends
respectively tapered at 110 and 110a. A heavy-duty woven fabric
belt 111 is joined to arcuate assembly half 102 by means of rivets
102. Although not shown for purposes of simplicity, belt 111 is
substantially an elongated member and, in one actual embodiment,
has a length of approximately 20 inches.
A buckle assembly 113 is mounted to assembly half 101 and is
comprised of a short section 114 of a heavy duty woven fabric belt
secured to assembly half 101 by rivets 115. The free end of the
short belt portion 114 is secured between a slightly curved
metallic sheet 116 and a narrow, elongated metallic sheet 117 by
means of rivets 118. The slightly arcuate shaped metallic sheet 116
is provided with a pair of ears 118 and 119 which are bent to
surround a rod 120 secured at its opposite ends to a
rectangular-shaped buckle member 121. The left-hand end of slightly
arcuate shaped member 116 is provided with a serrated edge 122
which cooperates with the buckle member 121 to lock belt portion
111 which has passed through the region designated by dotted line
111' so as to retain the assembly in the infusion state, which will
be more fully described hereinbelow.
As can best be seen from FIG. 2c, the short belt section 114 is
secured between a narrow, elongated plate 123 and assembly half 101
by the rivets 115. The belt extends further to the right of plate
123 and is looped over itself to form a narrow opening for a
substantially C-shaped clip 124 whose free ends 124a and 124b
extend into the opening formed in belt portion 114. The looped over
belt portion is sewn to the remaining belt portion, as shown by
dotted lines 125. Clip 124 is further provided with a second clip
126 which may be utilized to releaseably support or hang the
infusion bag assembly upon a belt loop, or any other structure for
that matter, to facilitate either carrying or actual usage of the
assembly.
The belt 111 is provided with a similar overlapped portion which is
retained against the main body of the belt by sewing the two
portions together, as designated by dotted lines 127. The bent-over
portion of the belt provides a narrow opening for receiving the
free ends 128a and 128b of a second clip 128 which, in turn, is
provided with an additional clip 129 for releaseably mounting the
assembly to any suitable structure or to a belt loop field pack, or
any other apparatus. Belt 111 is secured between assembly half 102
and an elongated metallic plate 130 by means of the rivets 112.
FIG. 2e is a sectional view of a portion of assembly half 102
looking in the direction of arrows 2e--2e' and shows the manner in
which the fabric sheets are joined together along the lower edge.
Metallic sheet 104 is positioned between the fabric sheets 106b and
105b. The marginal edge of fabric sheet 105b is bent under, while
the marginal portion of fabric sheet 106b is bent around the
marginal edge of metallic sheet 104. The engaging marginal portions
are sewn together at 131. The perimeters of both assembly halves
101 and 102 have their fabric sheets joined together in a similar
fashion.
FIG. 2b shows the assembly as being further provided with a
retaining means comprising a pair of sleeves 132 and 133 for
retaining compressible bags of fluids which may, for example, be
blood plasma, or any other sterile fluid which is to be infused
into the body of a patient. The sleeves are formed from a single
sheet of heavy-duty woven fabric material 134. One free end 134a of
the single sheet is secured to assembly half 102 by means of the
rivets 109. The sheet extends away therefrom to first form the
left-hand side, top side and right-hand side of sleeve 132. The
sheet then extends upwardly to form the left-hand side, top side
and right-hand side of sleeve 133, with the extreme free end 134b
extending beneath point 135 where the right-hand side of sleeve 132
and the left-hand side of sleeve 133 share a common boundary. The
single sheet is then sewn together at location 136. The thread
employed to sew the single sheet of fabric 134 to itself is also
further sewn through the center line of the single sheet comprised
of sheet halves 106a and 106b along the line coincident with the
central axis 108 of the assembly. If desired, one end of each
sleeve may then be sewn closed to form corresponding pockets.
It should be noted that sleeve 132 is larger than sleeve 133 so as
to accommodate a compressible plastic bag of larger size (and
hence, volume). For example, sleeve 133 may be adapted to
accommodate a compressible plastic bag of sterile fluid having a
capacity of 500 milliliters, while sleeve 132 may be adapted to
receive a compressible plastic bag having a capacity of 1000
milliliters. The sleeves (132 or 133) serve to retain a
compressible fluid bag between the arcuate plates while during the
time the plates are moved to the operating position. The manner of
use of the sleeves is as follows:
The compressible bag is inserted into the sleeve whose opening is
closest in size to the compressible fluid bag. Once the fluid bag
is inserted, the free ends of springy plates 103 and 104 are moved
from the position substantially as shown in FIG. 2b to the position
shown in FIG. 2d. Closure and locking of the plates is accomplished
by drawing belt 111 (see FIG. 2d) through buckle assembly 113.
Although the closing of the plates 103 and 104 would otherwise tend
to urge the compressible bag out from between the plates, the
sleeve prevents this from occurring.
One alternative arrangement to the sleeves 132 and 133 which may be
employed is shown in FIG. 2f and is comprised of an elongated strap
140 having a first end thereof 141 sewn or otherwise secured to
assembly half 101. The marginal portion of the free end of strap
140 may be provided with a strip 142 of an adhesive material which
may be releaseably secured to surface portion 143 provided along
the convex surface of assembly half 102 in close proximity to the
center line 108 of the assembly. As another alternative, a VELCRO
fastener assembly may be employed, wherein the strip 142 may be
comprised of the loop portion of a VELCRO fastener, while the strip
143 may be comprised of the hook portion of a VELCRO fastener so as
to releaseably join strap 140 to surface 143. As is well known with
regard to VELCRO fasteners such assemblies, when joined together,
are capable of remaining joined together even in the presence of
great shearing stresses which may be exerted thereupon.
In use, the compressible bag of sterile fluid 145 is positioned
between the two convex surfaces of assembly halves 101 and 102.
Strap 104 is positioned around the bag 145 in the manner shown best
in FIG. 2f. The strip 142 provided near the marginal end of strap
140 is then pressed against strip 143 so as to secure the
compressible bag 145 and prevent the bag from moving in the
direction shown by arrow 146. The free end of belt 111 is threaded
through the buckle assembly 113 in the manner shown in FIG. 2f, and
is then pulled in the direction shown by arrow 147 to draw the
outermost edges 101a and 102a of assembly halves 101 and 102 toward
one another until the two outermost edges are either in close
proximity or engage one another. The resilient arcuate shaped
metallic sheets 103 and 104 exert a counter-force which tends to
urge the infusion assembly halves 101 and 102 apart. However, the
belt 111, in attempting to be pulled away from the buckle assembly
113, engages the serrated edge 122 of plate 116 so as to remain
tightly fastened or wedged between the serrated edge 122 and buckle
member 121 to prevent the assembly halves from moving apart.
The resilient metallic sheets thereby exert significant force upon
the surfaces of the compressible bag of sterile fluid to cause the
sterile fluid to be urged out of the bag through (see FIG. 2d) a
piece of hollow tubing 148, valve 149, drip chamber 150 and tubing
151, whose free end is provided with a suitable hypodermic needle
152 which may be inserted into the body to infuse the fluid into
the body of the patient. Valve assembly 149 may be employed to
selectively cut off or enable fluid flow, while drip chamber
assembly 150 may be utilized to regulate the rate of flow.
The manner of use of the embodiment of FIG. 2b is substantially
similar to that shown in FIG. 2f, except that the compressible bag
of fluid is first inserted into the appropriate sleeve 132 or 133.
The free end of belt 111 is then inserted through the buckle
assembly in similar fashion to that described hereinabove to draw
the outer ends of assembly halves 101 and 102 together so as to
exert a significant compressive force upon the compressible plastic
bag of sterile fluid.
The primary and significant feature of the infusion bag assembly
resides in the fact that the assembly need not be positioned above
the body of the patient so as to rely upon gravity to insure flow
of the fluid from the bag or sterile container into the body. For
example, in battlefield situations, it may be quite impractical, if
not impossible, to mount a container of sterile fluid upon a
stretcher, whereby the container of sterile fluid is positioned
well above the height of the person being carried. With the present
invention, the infusion bag assembly may even be mounted at or
below the height of the person being carried or treated, since the
relatively large compressive forces of the assembly are more than
sufficient to squeeze the sterile fluid from the bag and into the
body of the patient. Accurate regulation of fluid flow may be
controlled through the use of valve 149 and drip chamber 150, or
through the use of any other suitable flow-regulating means.
FIG. 3 shows curves comparing the flow rate through the infusion
set of FIGS. 2a-2c. As shown in FIG. 3, Curve A represents the
infusion or expelling of a saline solution contained in a 1000 ml
bag for an apparatus as shown in FIGS. 2a-2c which is located at
the same height as the catheter. The curve indicates that the
entire contents are expelled in 12 minutes. Curve B represents the
flow rate for an infusion set of the type shown in FIGS. 2a-2c
which is located at a height of one meter above the catheter level.
It can be seen that the entire contents are expelled within nine
minutes.
Curve C represents the flow rate for a sterile fluid bag elevated
at a height of one meter above the catheter level and in the
absence of the infusion set hereof. It can be seen that 16 minutes
are required to expel the entire contents of the fluid container.
Similar results have been obtained for other solutions such as, for
example, a dextrin solution from which the entire contents of a 560
ml fluid container are expelled within 111/2 minutes, while 17
minutes are required to expel the entire contents of a bag
positioned at one meter above the catheter level in the absence of
the non-gravitational infusion set. The entire contents of a 560 ml
container can be expelled within 9 minutes when the infusion set of
FIG. 2a-2c is positioned one meter above the catheter level.
Similar results have been obtained for other fluids, including
blood.
When not in use, the assembly 100 may be made quite compact by
threading the belt 111 through the buckle assembly 113 in a manner
similar to that described above, with the exception that no
compressible bag of fluid be inserted between the assembly halves
101 and 102. The assembly 100 may then be carried in any suitable
mmanner such as inside of a field pack, clipped to the exterior of
a field pack, or clipped to a waist belt or any other suitable
place or location.
The assembly 100, which is formed of a very heavy-duty fabric and a
heavy-duty buckle assembly and fabric belt, is relatively
indestructible and have an extremely long, useful operating life.
In addition, the effectiveness of the assembly 100 will not be
reduced or significantly altered as a result of exposure to outside
elements or influences, such as rain, sleet, snow, salt water,
dirt, dust, or any other influences which may normally be
considered to be harmful. The arcuate shaped metallic sheets, in
one preferred embodiment, are preferably formed from a springy,
resilient steel, and it has been found that no significant
reduction in effectiveness of the plates has occurred even after
continued use, regardless of the conditions or situations in which
the assembly is used.
FIGS. 1a-1f show another preferred embodiment 10 of the present
invention, which is comprised of a plurality of arcuate shaped
metallic sheets 11 (a total of eight being employed in the assembly
shown in FIGS. 1a and 1c, for example). The assembly half 12
utilizes four of the arcuate shaped metallic sheets which are
arranged in side-by-side fashion and inserted within separate
sleeves 13-16, which sleeves are formed from a pair of heavy-duty
woven fabric sheets 17 and 18, which are sewn together along the
top, bottom and right-hand edges of assembly 12 and are further
sewn along lines 19, 20 and 21 so as to form four individual
sleeves which are open along their left-hand edges to permit
insertion of each of the associated arcuate shaped metallic sheets
11.
The metallic sheets 11 are each retained within their associated
sleeves by rivets 22. The rivets 22 further serve to secure one
cooperating portion of a clasp assembly, which portions are
designated by the numerals 23a-23d, respectively. Since the clasp
portions 23a-23d are substantially identical in design and function
to one another, only one such assembly will be described herein for
purposes of simplicity.
Considering assembly 23a, this clasp portion can be seen to be
comprised of a mounting bracket 24 having a pair of mounting
portions 24a-24b (see FIG. 1b), which portions are joined to sleeve
13 by rivets 22. Mounting portions 24a and 24b are integrally
joined to one another by means of a yoke portion 24c, which yoke
portion forms an opening for receiving the free ends 25a and 25b of
a clasp membler. Clasp member 25 is free to pivot about the yoke
portion in either direction, as shown by the double-headed arrow 26
of FIG. 1b.
The remaining half 12' of infusion bag assembly 10 is formed of two
heavy-duty fabric sheet members 17' and 18' similar to those
described hereinabove, which sheets are joined or sewn together so
as to form the separate sleeves 13'-16', each of which receives one
of the arcuate-shaped metallic plates 11.
Assembly half 12' is provided with four clasp portions 27a-27d,
each of which cooperate with an associated clasp portion 23a-23d,
respectively, in a manner to be more fully described. Since each of
the clasp portions 27a-27d are similar in design and function, only
one will be described herein for purposes of simplicity.
The assembly 27a is comprised of a mounting bracket 28 having a
pair of similar mounting halves 28a and 28b secured to sleeve 13'
by rivets 22'. The mounting portions 28a and 28b are integrally
joined to one another by a yoke portion 28c which has a
substantially triangular shaped configuration, as can best be seen
from FIG. 1b, so that the head portion may be snappingly received
by the associated buckle 25, in a manner to be more fully
described.
The manner in which the infusion bag assembly 10 is put into use is
as follows:
A compressible plastic bag of sterile fluid 145 is positioned
between the convex surfaces of assembly halves 12 and 12' in the
manner shown best in FIG. 1b. Halves 12 and 12' are then moved
toward one another in the directions shown by arrows 29a and 29b
until the outer free ends of assembly halves 12 and 12' are brought
into engagement. Each of the buckles 25 is then snapped over its
associated head 28c where they remain locked in the position shown
best in FIG. 1e. The highly resilient arcuate shaped metallic
members exert a relatively high compressive force against bag 145
to squeeze the fluid from the bag and preferably through the valve,
drip chamber and injection or hypodermic needle assembly of the
type shown best in FIG. 2d. It should be understood that all four
clasp assemblies are locked into position in the manner shown best
in FIG. 1e.
For a device of the type similar to that shown in FIGS. 1a-1c
comprising three pairs of curved, springy, metallic sheets (formed
by cutting a cylinder of metallic material in half and by cutting
each of the halves into three parts), the initial pressure applied
to a compressible fluid bag was 0.15 atmospheres (equal to about
1.5 meters of water) which yielded a flow rate of approximately 100
ml per minute at the initial stages, which flow rate decreased to
about 70 ml per minute near the end of the infusion.
The use of separate arcuate shaped metallic sheets in each half 12
and 12' of the assembly as opposed to the use of only a single
arcuate-shaped metallic sheet as in the case of assembly 100 of
FIG. 2, for example, facilitates locking of the clasp assemblies,
since the arcuate shaped metallic sheets of significantly smaller
size individually exert smaller counteracting forces, thereby
making it easier to latch each of the individual clasps.
Although not shown for purposes of simplicity, the assembly 10 of
FIGS. 1a-1f may be provided with a releaseable clasp or other
hardware for suspending the infusion bag assembly 10 from a
stretcher or a field pack, for example, either during use or while
being transported.
FIG. 1d, which is a sectional view of a portion of the assembly
shown in FIG. 1c taken along the lines 1d--1d', shows the manner in
which the fabric sheets are sewn together. Fabric sheet 18 has its
marginal edge folded around the marginal edge of the arcuate
metallic sheet 11. Fabric sheet 17 has it marginal portion folded
under so that the two engaging portions may be sewn as shown at the
location designated by numeral 31. The fabric sheets are further
sewn together as shown by numeral 21 to form the two separate
sleeves 16 and 15, each of which is adapted to receive one of the
arcuate shaped metallic resilient sheets 11, 11. The remaining
peripheral portions of the assembly halves 12 and 12' are sewn
together in a similar fashion.
When not in use, the assembly 10 may be made quite compact either
by drawing the two concave surfaces toward one another in the
manner shown in FIG. 1f or, alternatively, by bringing the two
convex surfaces toward one another in the manner shown in FIG. 1e,
with the exception that no compressible sterile fluid bag is
inserted therebetween. The clasps are then joined either in the
manner shown in FIG. 1f, or in the manner shown in FIG. 1e to
render the assembly quite compact during either storage or
transportation thereof. If desired, a compressible bag may be
stored between the members 12 and 12' when in the position of FIG.
1f. The plates exert only a mild force upon the compressible fluid
bag so as not to stress the bag when not in use. The distinct
advantage of storing compressible bags in this manner is to protect
the compressible bag during storage, handling or transportation.
The embodiment of FIG. 2 may be utilized in a similar fashion.
As another obvious alternative, the assembly 10 of FIGS. 1a-1f may
be provided with a strap of the type shown in FIG. 2e, or one or
more sleeves of the type shown in FIG. 2b to facilitate retention
of the compressible sterile fluid bag between the convex surfaces
of the assembly halves 12 and 12' so as to retain a compressible
fluid bag between the assembly halves when they are moved to the
position of FIG. 1e.
As another possible alternative to the preferred embodiments of the
present invention, any other suitable hinge means may be employed
for pivotally connecting the curved, springy, metallic sheets in
addition to the employment of the heavy-duty fabric sheets as the
means for pivotally connecting the metallic sheets.
It can be seen from the foregoing description that the present
invention provides a novel non-gravitational infusion bag set for
squeezing sterile fluid, and the like, from a compressible fluid
bag, wherein the assembly is quite compact to facilitate storage
and transportation, while having a unique design to enable infusion
of sterile fluid, and the like, from a compressible bag in a
non-gravitational manner, thus eliminating the need for mounting or
supporting the sterile fluid container a significant distance or
height above the body of the patient, as is required in
conventional infusion techniques which primarily rely upon
gravitational flow. The assembly is thus uniquely adapted for use
in situations in which fluid flow by gravity is either impractical
or impossible, such as, for example, the use in battlefield, riot
or other disaster conditions which restrict or otherwise render
impossible the infusion of a fluid into a patient through normal
gravity flow techniques.
Although this invention has been described with respect to
particular embodiments, it should be understood that many
variations and modifications will now be obvious to those skilled
in the art, and, therefore, the scope of this invention is limited
not by the specific disclosure herein, but only by the appended
claims.
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