U.S. patent number 3,779,507 [Application Number 05/179,510] was granted by the patent office on 1973-12-18 for means for controlling fluid flow.
Invention is credited to Ellis Whiteside Clarke.
United States Patent |
3,779,507 |
Clarke |
December 18, 1973 |
MEANS FOR CONTROLLING FLUID FLOW
Abstract
A device for regulating fluid flow, especially of blood, saline
drips and other medical fluids in hosp1tal administration sets, is
in the form of a clamp having jaws engaging a flattened portion of
tube, and this flattened portion has a tapered groove or a tapered
elongated member between its opposed walls. Movement of the point
of action of the clamp along the flattened tube portion varies the
rate of flow.
Inventors: |
Clarke; Ellis Whiteside
(Belfast, EI) |
Family
ID: |
26247868 |
Appl.
No.: |
05/179,510 |
Filed: |
September 10, 1971 |
Foreign Application Priority Data
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|
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Sep 11, 1970 [GB] |
|
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43,513/70 |
Apr 23, 1971 [GB] |
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10,934/71 |
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Current U.S.
Class: |
251/9; 251/4 |
Current CPC
Class: |
A61M
39/284 (20130101) |
Current International
Class: |
A61M
39/28 (20060101); A61M 39/00 (20060101); F16k
007/06 () |
Field of
Search: |
;138/45
;251/4-6,9,10 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Schwadron; Martin P.
Assistant Examiner: Gerard; Richard
Claims
I claim:
1. Means for controlling fluid flow comprising a hollow tubular
body, a longitudinally extending flattened portion in said body,
said flattened portion having two opposed flexible walls capable of
being brought into mutual contact, a clamp, said clamp having
opposed jaws capable of engaging externally said walls over a
longitudinally limited region thereof whereby to bring said walls
forcibly into contact only over said region, the unclamped portions
of said opposed walls being capable of flexing outwardly under
fluid pressure to define between them a fluid duct of relatively
large cross-sectional area if not already flexed outwardly by their
own innate resilience to define such a duct, longitudinally
extending tapered means disposed between said opposed walls to
define a fluid passage therebetween even when said walls are in
mutual contact, the cross-sectional area of said passage varying
longitudinally by virtue of the taper of said tapered means, and
the region of engagement of said jaws on said flattened portion
being movable longitudinally of said flattened portion.
2. The means set forth in claim 1 wherein said tapered means
comprise surfaces defining a longitudinally extending tapered
groove in the inner surface of at least one said walls.
3. The means set forth in claim 1 wherein said tapered means
comprise a tapered elongated member extending longitudinally
between said walls and serving to keep said walls apart locally
against the action of said clamp.
4. The means set forth in claim 1 wherein said tapered means do not
extend the full longitudinal extent of said flattened portion.
5. The means set forth in claim 1 wherein said body is of
thermoplastic synthetic resin.
6. The means set forth in claim 1 wherein said clamp comprises
first and second lever members, asid lever members lying on
opposite sides of said flattened portion, means defining a rocking
hinged connection between said lever members, and resilient means
urging one pair of adjacent ends of said lever members together,
said ends defining said jaws and clamping said flattened portion
therebetween.
7. The means set forth in claim 6 wherein said resilient means
comprise at least one elastic loop embracing said ends.
8. The means set forth in claim 6 wherein said jaws have mutually
parallel faces and, in the rest condition of the lever member under
the action of said resilient means, with said jaws engaging said
flattened portion, said hinged-connection-defining means are out of
mutual hinging engagement.
Description
This invention relates to means for controlling the flow of a fluid
(primarily a liquid, although the invention may also be used to
control gas flow) by means of an adjustable clamp acting on the
walls of a flexible-walled tube.
Such clamps are used in medical equipment to control the flow of
blood or saline fluid or other medical fluid to the body of a
patient from a container which is usually suspended above the
patient to allow the flow to take place by gravity under the
control of the adjustable clamp. It is necessary to be able to
adjust the flow over a range of values, all small, of the order of
400 millilitres and hour down to as little as a millilitre per
hour, under a head of about 75 cm. Such clamps are widely used, in
the form of a ribbed roller movable along a channel-like guide that
receives a flexible tube of plastics material, the opposing wall of
the guide being inclined at an acute angle to the path of the
roller, so that by moving the roller along the guide one can adjust
the degree of flattening of the tube. Such a clamp forms the
subject of U.S. Pat. specification No. 3,099,429. Another proposal
on these lines is shown for example by U.S. Pat. specification No.
1,330,523 and a clamp employing a slide with an inclined surface
but no roller is shown in U.S. Pat. specification No. 3,497,175.
This last-mentioned specification discloses also a straightforward
screw type of clamp, another example of which is shown by French
Pat. specification No. 1,206,243.
However tests have shown that the roller type of clamp, although
very widely used, is far from ideal as its adjustment is
undesirably coarse, especially in the lower part of the flow range
and, more seriously, the flow rate does not remain constant at the
value to which it has been adjusted. In tests it has been found
that the flow rate generally falls exponentially from the set value
to a value which may, after some hours, be only about half that to
which it was set. This is because of recovery in the plastics
material of the tube walls. Consequently nursing staff have to
check and re-adjust the clamp frequently, taking up valuable
time.
The primary aim of the present invention is to overcome this
drawback and to provide a tube clamp which can be adjusted in small
steps and which moreover maintains the flow rate indefinitely at
substantially the rate set.
According to the invention I now propose means for controlling
fluid flow comprising a passageway having opposed flexible walls
which are capable of being held in mutual contact throughout their
cross-section except for a limited region, this region being of
cross-section which varies along the general direction of flow
through the passageway, with an externally applied clamp of which
opposed jaws hold the walls in contact over a localised area of
limited axial length, the jaws being movable along the direction of
flow to other positions, along this direction of flow to alter the
position, along this direction of flow, of the said area.
Preferably the region in which the walls are not in mutual contact
is formed by a groove in one of the walls or, better still,
mutually aligned grooves in both walls, that define a tapering
passage of round or substantially round cross-section. In the area
where the jaws of the clamp hold the walls in mutual contact only
this round passage forms a path for the fluid, but upstream and
downstream of this area the flexible nature of the walls allows the
walls to move apart under even slight pressure, so that the
cross-section for flow away from the selected area is large. Thus,
by moving the clamp along the passageway one can alter that portion
of the tapered pasage which forms the flow-controlling orifice, and
one can thus regulate the flow.
The walls are preferably formed by the opposed walls of an
initially round tube of plastics material which has been
permanently flattened by a heating and moulding operation.
Instead of providing a groove or grooves in the walls, I could
leave the walls smooth but hold them positively apart in a
localised region by means, for example, of a filament, preferably a
tapering one, the behaviour being similar to that of the grooved
version in that the fluid is only able to pass, in the area engaged
by the jaws of the clamp, in the spaces formed immediately
alongside the filament whereas upstream and downstream of this area
the walls are able to move apart and allow ample cross-sectional
area for flow.
The invention will now be further described by way of example with
reference to the accompanying drawings, in which:
FIG. 1 is a general view of part of a medical fluid administration
set, showing the manner in which the clamp according to the
invention can be used;
FIG. 2 is a view, partly sectioned, of a length of tube to which
the clamp is applied, but with the clamp omitted;
FIG. 3 is a view perpendicular to that of FIG. 2, showing the clamp
in place;
FIG. 4 is a section through the clamp, to a larger scale;
FIG. 5 is a perspective view of one component of the clamp;
FIGS. 6 and 7 are respectively transverse and longitudinal
cross-sections through a die suitable for moulding the tube to
receive the clamp; and
FIG. 8 is a perspective view, partly broken away, of an alternative
version of the tube shown in FIG. 2.
Referring first to FIG. 1 a typical medical administration set, for
administering fluids such as blood or saline fluid to a patient in
hospital, comprises a tube 1 carrying a hollow needle 2 at its
upper end for inserting through a membrane in the cap or wall of an
inverted reservoir or container (not shown) holding the fluid to be
administered, an air venting branch 3, a filter bag 4, a
transparent bag 5 for observing the rate of flow by counting the
drops of fluid falling through it, and an outlet tube 6 leading to
the patient. The clamp according to the invention, shown generally
at 7, is applied to this outlet tube.
The tube 6 is made of flexible thermoplastic synthetic resin, such
as polyvinyl chloride. To prepare it to receive the clamp, part of
the length of such tubing is permanently flattened, for example by
means of a die such as that shown in FIGS. 6 and 7. It will be seen
that this die comprises two co-operating parts 8 and 9 which do not
merely squash the tube flat, which would leave two ends of the oval
cross-section still rounded, to leave a passageway of dumb-bell
shape, but mould the tube to a rectangular profile with a
passageway in the form of a plain slit which, in the rest
condition, is of zero cross-sectional area. For this purpose the
aperture in the die is only of exactly the same cross-sectional
area as the materal of the tube itself. The flattening is performed
with the application of sufficient heat to allow the material of
the tube to flow and take a permanent set, with substantially no
recovery, nearly in the shape shown in FIG. 6. However the degree
of shaping is preferably such that in the free condition, i.e.,
with zero pressure difference across them, the walls do have a
tendency to separate slightly.
Before the tube is placed in the die there is inserted in it a thin
tapered body, for example a fine tapered metal needle or uniformly
tapered wire, as indicated at 10 in FIG. 6. This wire or needle is
removed after the moulding operation and leaves in the opposing
inner surfaces of the two walls of the flattened portion 11 of the
tube a pair of mutually aligned co-operating grooves 12 which taper
from a maximum cross-section at one end of the flattened portion 11
down to zero before the other end is reached. In a typical example
the tapered portion is 11/2 inches (38 mm) long.
The needle or tapered wire 10 can be made by selective electrolytic
etching of an initially uniform wire. As it is very fragile, it can
be enclosed in a tube of stainless steel, which is inserted in the
plastics tube 6 with the wire inside it. Then the stainless steel
tube is carefully withdrawn, leaving the wire 10 inside the
plastics tube, which is then placed in the die 8, 9.
The degree of heat and pressure applied in the die 8, 9 should be
such that, in the finished tube 11 the opposed walls came into
mutual contact throughout their area (except where the grooves 12
are) under negligible external pressure, but at the same time any
even slight internal pressure will force them easily apart. It may
even be such that, in the unstressed condition, the walls do bow
slightly apart.
The clamp comprises a pair of co-operating lever members 13 having
a mutual pivoting or rocking action so that jaw portions 14 of
these lever members grip between them a localised area of the
flattened tube 11 with an action not unlike that of a clothes peg.
In the preferred embodiment illustrated, the lever members 13 are
identical mouldings in synthetic resin, for example a silicon resin
or polystyrene.
To locate the two members 13 with respect to each other they are
provided with co-operating lugs 15 that form a rocking hinge.
Additional lugs 16 limit the rocking movement so that the opposite
ends of the members 13 from the jaw portions 14 cannot themselves
close onto the tube and interfere with movment of the clamp along
the tube; flanges 17 help to locate the clamp on the tube portion
11, and lugs 18 on the jaw portions 14 keep these ends of the
members 13 in alignment.
The jaw portions 14 of the members 13 are urged together by two
resilient loops 19 encircling these portions and located in
suitable grooves formed in the external faces of these portions.
The loops are conveniently ordinary rubber bands and there are two
of them so that failure of one will not result in total failure of
the clamp.
The co-operating inner faces of the jaw portions 14 are flat and,
to ensure that they engage the tube 11 squarely, i.e., so that they
are truly parallel, the shape and position of the hinge lugs 15 are
such that these lugs are out of mutual contact in the rest position
of the clamp. They only come into engagement when the serrated
finger-engaging ends 20 of the members 13 are manually squeezed
together to open the clamp. Thus the jaws 14 are truly parallel,
independently of slight variations in the thickness of the tube
11.
It will be understood that, with the clamp 7 engaged on the
flattened portion 11 of the tube, the rate of flow through the tube
is controlled by the smallest cross-sectional area of the grooves
12 in that area of the tube which is gripped by the jaw portions
14. Upstream and downstream of this area (subject to the comment
below) the walls of the tube are free to move apart under the
pressure of the fluid to provide a relatively large cross-sectional
area. Thus by moving the clamp 7 along the flattened portion 11 to
a region wbere the tapered passage formed by the grooves 12 is
larger or smaller one can increase or decrease the rate of flow of
the fluid, and by moving the clamp to the area beyond the small end
of the grooves 12 one can cut off flow altogether. As will be seen
in FIGS. 2 and 3 I can form a partially flattened portion 21 on the
tube to provide clearance for the ends 20 of the clamp when the
clamp is at this end of the portion 11.
In many situations it is immaterial whether the larger or the
smaller ends of the grooves 12 are upstream as the behavior device
is the same in each case. However, with a layout such as that shown
in FIG. 1 it is possible for the fluid pressure downstream of the
clamp to be below atmospheric pressure, and consequently the walls
of the flattened portion tend to close up, and this could lead to a
restriction or cut off of the flow regardless of the position of
the clamp 7 if the flow were to be from the larger to the smaller
end of the tapered grooves 12. Preferably, therefore, I arrange for
the flow to be the other way, that is to say, from right to left in
FIGS. 2 and 3. Similarly, the device works equally well with the
clamp 7 facing either way but in practice, in a layout like that of
FIG. 1, it is possible for twisting of the tube 6, such as can
arise in use under hospital conditions, so the flattened portion 11
upstream of the clamp 7 can become twisted, which tends to close it
up even against the fluid pressure inside. I therefore prefer to
arrange the clamp 7 as shown in FIGS. 1 and 3, that is to say with
the finger-engaging ends 20 upstream, as these ends, being close to
the tube 11, prevent twisting of the tube.
The device according to the invention is preferably formed in a
separate short length of tube, which can then be of slightly harder
material than the normal polyvinyl chloride forming the remainder
of the tube 6. It can be joined to the remainder by short internal
sleeves as indicated at 6a in FIG. 2.
The flattned portion 11 may have markings on it, for example
transverse lines, to enable the user to move the clamp rapidly to a
known position to set the flow to a required value. The clamp may
be held in place by adhesive tape binding one of the ends 20 to the
tube. Where it is desired to allow maximum flow without the
restriction imposed by the clamp 7, the clamp can be held open by a
resilient sleeve which is slipped over the ends 20 to hold the jaws
open. This sleeve can be permanently on the tube, normally just
clear of the end position of the clamp 7. The ends 20 may have
projections (not shown) to be engaged by the sleeve. An easier
alternative for holding the clamp open, in place of such sleeve, is
simply for the user to push the clamp along to a position where the
jaw portions 14 engage the unflattened part of the tube 6, for
example the region where the internal sleeve 6a is present, the
internal sleeve preventing the tube collapsing.
In an alternative version, illustrated in FIG. 8, the grooves 12
are omitted altogether and in place of them there is a
longitudinally extending tapered wire or filament 22 placed between
the walls of the flattened portion 11. Flow takes place in the
roughly triangular spaces that are left between the walls
immediately on each side of the filament. As before, the flow is
controlled by moving the clamp longitudinally. This version is
however less satisfactory as the rate of flow may be influenced by
the pressure applied by the jaws, this pressure being a somewhat
indeterminate quantity.
It will be understood that the form of the clamp may be different
from that shown, the only essential thing being that it acts only
on a area of the tube walls of limited longitudinal extent. For
example, there could be a jaw formed by a flat stationary plate
forming a backing or anvil lying on one side of the flattened
portion and extending the full axial length. The other side of the
flattened portion is engaged by a bar, forming the other jaw, which
is slidable in guides associated with the anvil. Instead of a bar
there could be a roller, not unlike that of U.S. Pat. specification
No. 3,099,429, except that its spacing from the anvil would remain
constant, instead of varying, as it is moved longitudinally.
* * * * *