U.S. patent number 3,797,486 [Application Number 05/320,183] was granted by the patent office on 1974-03-19 for intravenous infusion assembly.
Invention is credited to Robert S. Shaps.
United States Patent |
3,797,486 |
Shaps |
March 19, 1974 |
INTRAVENOUS INFUSION ASSEMBLY
Abstract
An improvement for intravenous surgical needle assembly that is
implanted in the patient for a relatively long period of time for
intermittent intravenous injections. The improved assembly includes
a chamber or reservoir holding a supply of a second fluid to be
introduced through the intravenous needle, usually an
anti-coagulant, and a valve to selectively close off the second
fluid's circulation therethrough while allowing the principal fluid
to flow intravenously; and alternatively close off the principal
fluid flow while allowing the second fluid to circulate from the
reservoir in and through the surgical needle, usually for the
purpose of preventing coagulation in and about the tip of the
needle.
Inventors: |
Shaps; Robert S. (San
Francisco, CA) |
Family
ID: |
23245243 |
Appl.
No.: |
05/320,183 |
Filed: |
January 2, 1973 |
Current U.S.
Class: |
604/246; 604/257;
251/342 |
Current CPC
Class: |
A61M
39/02 (20130101); A61M 39/22 (20130101) |
Current International
Class: |
A61M
39/22 (20060101); A61M 39/02 (20060101); A61M
39/00 (20060101); A61m 005/00 (); A61m
001/00 () |
Field of
Search: |
;128/214R,2,DIG.5,276,2.5R,2.5DX,12 ;137/602,607,610,612X
;251/342X |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Medbery; Aldrich F.
Attorney, Agent or Firm: Warren, Rubin, Brucker &
Chickering
Claims
I claim:
1. In an intravenous assembly for the injection of a principal
fluid into a blood vessel of the human body, said assembly having a
hollow needle for fluid communication with the source of said fluid
and a tip for infusion into the blood vessel, and wherein said
assembly is adapted to remain implanted in a human vessel for
repeated injections over a period of time, the improvement to
selectively provide said assembly with a second fluid at said
needle tip to prevent coagulation of blood therein comprising;
a reservoir chamber adapted to carry a supply of said second
fluid;
a flexible walled hollow coupling having an open end for fluid
communication from within said reservoir chamber into said coupling
and an opening formed in said coupling adapted to receive said
principal fluid therethrough into the coupling from a source of
such fluid, said coupling formed with an open terminus adapted to
receive the posterior end of said hollow needle;
valve means carried by said coupling for selectively closing off
said opening for principal fluid and said open end in communication
with said second fluid reservoir, said valve means comprising a
substantially rigid valve flap; and position holding means on the
coupling for engaging said flap, whereby principal fluid from a
source thereof may be infused intermittently through said needle
via said coupling and said second fluid may be delivered into the
needle from said reservoir chamber between injections of principal
fluid.
2. The improvement in an intravenous assembly as defined in claim 1
and wherein
said flap is shaped to overlay said open end and said opening;
means pivotally mounting said flap on the inside of the wall of
said coupling in position to selectively overlay said open end and
said opening; and means secured to said flap and having a portion
thereof external to said coupling for selectively positioning the
flap to overlay said open end and, alternatively, said opening.
3. The improvement in an intravenous assembly as defined in claim 2
and wherein further the wall of said flexible coupling is
fabricated of a relatively pliable material; said means secured to
said flap having a portion external to said coupling comprises a
nodule fabricated of a relatively stiff material, said nodule
sealably secured through said coupling wall to said flap along the
pivotal axis thereof and extending outwardly therefrom, and shaped
for manual engagement to cause said flap to overlay said opening
when the nodule is in one position, and to overlay said open end of
the coupling when manually displaced to another position; and means
proximate said opening and said open end to hold said flap firmly
in position when the latter is positioned to overlay said opening
and, alternatively, said open end.
4. The improvement in an intravenous assembly as defined in claim 1
and wherein further said coupling is fabricated to provide said
open end adjacent to said opening for principal fluid, said open
end and said opening shaped to have substantially the same
cross-sectional area and shape; said coupling being fabricated of a
relatively pliable material; and
said valve means comprises:
a flap shaped to overlay said open end and said opening; means
mounting said flap inside said coupling in position to selectively
overlay said open end and said opening; and
said holding means being proximate said opening and comprising a
clasp to hold said flap firmly in position when the latter is
positioned to overlay said opening and, alternatively, said open
end, whereby
said flap may be maneuvered by manually squeezing the coupling in
the vicinity of said flap and causing the latter to be moved in
position to overlay said open end to block flow of said second
fluid and allow principal fluid to flow through said opening and
coupling into and through said needle, and, alternatively cause the
flap to be moved in position to overlay said opening to block flow
of said principal fluid and allow said second fluid to flow through
said open end into and through the needle.
Description
This invention relates to intravenous injection assemblies such as
commonly employed to provide a patient with a principal fluid
machine therethrough and which may remain implanted in the patient
so that repeated injections may be made over a period of time. More
specifically my invention is directed to an assembly to selectively
provide the injection needle with a second fluid at the tip thereof
to prevent coagulation of blood therein, so that long term
implantation is not complicated by the need to withdraw the needle
from the patient.
Intravenous injection of fluids such as glucose solutions are often
called for over an extended treatment period but at interrupted
intervals. Withdrawal and reinjection of the surgical intravenous
needle is a source of great discomfort to the patient; and is time
consuming and often inconvenient to the nurse or physician
responsible, since such personnel may be involved in other
essential duties elsewhere.
To help overcome the foregoing problem, intravenous assemblies are
available which include plastic wings attached at one end of the
needle. Once the needle is injected into the patient--usually a
vein in the patient's arm--the aforementioned wings are taped to
the patient's arm thus retaining the needle implanted within
minimum movement.
The problem, however, that arises in these circumstances is that
between active injections of principal fluid into the patient's
blood stream, the blood which inevitably finds itself into the
hollow needle, and especially at the tip, tends to coagulate so
that subsequent injections may be blocked. This difficulty in turn
has been overcome by providing the injection set up with a second
fluid, usually an anti-coagulant such as heparin solution. Such
solutions are introduced from a separate heparin vial by first
removing the principal fluid tube from the intravenous assembly and
substituting the heparin reservoir.
The foregoing described procedure too has disadvantages. First,
removing the principal fluid tube from the input or injection site
and substituting the second fluid vial requires manipulation of the
intravenous assembly implanted in the patient. Consequent movement
to achieve this may be painful to the patient, and at best is an
awkward arrangement. Second, the manipulation is inconvenient and
time consuming for the attending nurse or physician.
I am familiar with some prior art devices intended to solve certain
problems encountered in extended intravenous treatment. For
example, see the U.S. Pat. No. 3,276,472 to Jinkens patented Oct.
4, 1966; the U.S. Pat. No. 2,999,499 to Willet patented Sept. 12,
1961; and the U.S. Pat. No. 2,656,835 to Eisenstein patented Oct.
27, 1953. However, each of these references is directed to
different problems from those which I have described above, e.g.,
simultaneous injection of two fluids, and the structures developed
by these inventions are distinctly different from that which I will
describe and claim herein.
Thus it is an object of the present invention to provide an
intravenous needle assembly having a reservoir or chamber for
holding a second fluid for injection therethrough, and a valving
arrangement to selectively close off the second fluid while
permitting the principal fluid to be injected; and alternatively
close off flow of the principal fluid and allow the second flow to
circulate therethrough.
A feature and advantage of my invention is that in extended and
intermittent intravenous treatment, an anti-coagulant fluid may be
introduced through the infusion needle to prevent clogging of the
needle tip between principal fluid injections without the necessity
of disconnecting and clamping the principal fluid supply tube,
replacing the latter with the second fluid source, and later
reversing the procedure to reconnect the principal fluid
source.
A further feature and advantage therefore of my invention is that
in the course of extended intravenous treatment the patient is
spared unnecessary disturbance of the implanted infusion needle and
possible consequent pain and discomfort. At the same time the
attending nurse or physician avoids loss of time and inconvenience
normally required to carry out such procedures.
Numerous other objects, features and advantages of my invention
will be apparent to one of ordinary skill in the art to which it
pertains upon a reading of the below specification and with
reference to the accompanying drawing wherein FIG. 1 is an overall
plan view of an intravenous assembly embodying my invention;
FIG. 2 is an enlarged sectional view of a portion of the assembly
shown in FIG. 1;
FIG. 3 is an overall plan view of an intravenous assembly embodying
an alternative embodiment of my invention;
FIG. 4 is an enlarged sectional view of a portion of the assembly
shown in FIG. 3; and
FIG. 5 is a sectional view to illustrate an alternative detail of
my invention.
My invention may be understood by turning first to FIG. 1 wherein I
show an intermittent infushion set 12 comprising hollow injection
needle 14 having attached thereto a pair of plastic leaves or
so-called butteryfly 16, the latter for taping the entire assembly
to the patient's body, usually at the arm, after needle tip 14a has
been piercingly inserted into a blood vessel of the patient, most
generally a prominent vein. The posterior portion of needle 14
extends rearwardly of butterfly assembly 16 to an enlarged section
14b adapted for frictional or threaded (FIG. 2) attachment to
coupling 22 of fluid selector assembly 18.
As stated in the introduction of this specification, it is a
particular object of my invention to provide an improved
intermittent infusion assembly wherein, after implantation of
needle 14 into the vein of a patient, principal fluid, for example
a glucose solution, may be injected from its source bottle (not
shown) through tube 20 and coupling 22 selectively with respect to
a second fluid carried by chamber or reservoir 24; and thereafter,
after a predetermined amount of principal fluid is delivered to the
patient through needle 14, close off the flow of such fluid through
tube 20 and cause second fluid from reservoir 24 to circulate
through needle 14, particularly in and about implanted tip 14a. The
second fluid may for example comprise an anti-coagulant, such as
heparin solution, to prevent coagulation of blood at tip 14a and
hence clogging which would interfere with a later reinjection of
principal fluid.
The aforementioned desired selectivity of principal and second
fluid is achieved in accordance with the present invention by means
of selector assembly 18 best seen by reference to FIG. 2. More
specifically I show there the arrangement whereby principal fluid
tube 20, coupling 22, and reservoir throat 26 are formed to provide
a common confluence chamber 28 within coupling 22. The coupling is
of hollow construction having an open end 30 which provides fluid
communication from within reservoir 24 into the coupling. One
portion of the coupling wall is also formed to provide opening 32
which normally receives tube 20, the conduit carrying principal
fluid medicine from its source (not shown) to the coupling. Open
terminus 34 is provided at the opposite end of the coupling to
receive the enlarged posterior portion 14b of the hollow surgical
needle.
Specific flow control through the selector assembly is achieved by
the valve assembly at 36 carried by the coupling. One version of
this aspect of my invention is shown at FIGS. 1 and 2, principally
FIG. 2. Coupling 22 is fabricated so that open end 30 and opening
32 are closely adjacent to each other--in the embodiment shown
these openings lie at right angle to each other and nearly at its
apex--and further each of the openings is formed to have
substantially the same cross-sectional area and shape. Flap 38 is
flexibly secured to the inside of the coupling along pivotal axis
40 and is thus located to overlay either open end 30 or opening 32,
depending upon the position of nodule 42 explained below; and flap
38 has a cross-sectional area and shape substantially identical to
that of the openings it selectively overlays.
Flap 38 is controlled by manually adjusting nodule 42, the latter
being sealably secured through the coupling wall to the flap. By
pressing nodule 42 upwardly, until engagement of the flap with
clasp 44, open end 30 is close off leaving opening 32 open; by
pressing the nodule in the opposite direction, until flap 38 is
held by clasp 46, opening 32 is closed off leaving open end 30
open.
The foregoing describes one embodiment of my invention, apparatus
therefor, and operation by which I obtain the desired result of
controlling the flow of principal fluid medicine from a source
thereof for intermittent infusion. At the same time, and using the
same patient-mounted infusion set assembly, I can inject and make a
second fluid continuously available at and about the needle tip,
until the next principal fluid injection is called for. Such second
fluid may be an anti-coagulant such as heparin solution; and the
technique for utilizing such second fluid made possible by my
invention has the further advantage of eliminating the need for
additional syringe operations before subsequent principal fluid
medicine injections.
Further, as can be appreciated from the foregoing description, a
patient may move about comfortably between principal fluid
injections, without having to have a regular intravenous bottle
dripping into his infusion needle in order to prevent coagulation;
or without having to have heparin vials in makeshift manner
reattached to the ordinary infushion needle assembly, thus
incurring extra time and inconvenience to attendants and patients,
and possible pain and discomfort to the patient.
My invention thus far described utilizes a mechanical flap mounted
within coupling 22, and an external manual actuator in the form of
nodule 42. Alternatively, I prefer the less costly and complicated
expedient of fabricating the coupling itself of a relatively
pliable material, such as many commonly available inert plastics;
and to fabricate the flap of a relatively stiff material, also
known in the field of plastics. In this manner complicated
mechanical arrangements are avoided, because the pliability of the
coupling permits manual movement of the flap to either of the
aforedescribed positions. The pliable coupling is fabricated to
yield physically to permit movement of the stiff flap but without
damage to the coupling's operation.
In this connection I show an alternate embodiment of my invention
at FIGS. 3 and 4 which eliminates the external control nodule 42.
In this version of my invention I enjoy the advantage of not only
eliminating a part, nodule 42, but of simplifying the structure and
its operation to rely merely on external pressure manually applied
to pliable coupling 22 to move flap 38 from one operable position
to another.
In this version of my invention I prefer to orient the axes of
reservoir 24 and principal fluid tube 20 at acute angles 40' and
42' respectively, to the axis of coupling 22, rather than the
in-line and right angle arrangement of reservoir and tube preferred
in the embodiment explained above in respect of FIGS. 1 and 2. As
explained before, the throat opening of reservoir 24, which also
constitutes open end 30 of coupling 22, is of the same shape and
cross-sectional area as opening 32 that receives tube 20. Flap 38
is pivotally mounted along longitudinal axis 40 to the pliable
coupling wall between open end 30 and opening 32. Due to the
pliability of the coupling wall material, flap 38 may be maneuvered
to either of its overlaying positions (explained in detail above)
by manual pressure applied as indicated by outline of user's hand
44' (FIG. 3).
Another alternative arrangement of one portion of my invention is
shown at FIG. 5, namely another structure for the valve assembly
indicated at 36 in FIG. 2 and more fully explained herein above.
The alternative valve assembly 136 which appears at FIG. 5 has
certain advantages which may be preferred both in manufacture and
use. For example, this alternative is more positive in its action;
and operation of the assembly does not depend upon pliability of
the surrounding plastic material, thus permitting the entire unit
to be manufactured in a broader range of materials, including even
certain types of glasses and hard plastics.
More specifically assembly 136 comprises hollow plug 138 shaped to
fit slidably within principal fluid tube 120. Both plug 138 and
tube 120 are of circular cross-section, and the plug is formed to
fit sealably within the fluid tube. Additionally, plug 138 is
provided with closed end 138a and open end 138b opposite thereto.
Aperture 140 provides a radial opening into the hollow portion of
the plug, such aperture being closed off when the plug is in
position as shown by the solid lines of FIG. 5. Plug 138 is also
provided with a nodule 142 which extends radially outwardly through
slot 144 formed in the upper portion of tube 120.
As may be appreciated from the above description, plug 138 may be
manually maneuvered from the position shown by the solid lines in
FIG. 5, to that characterized by the dashed lines therein. In the
latter position aperture 140 is uncovered so that principal fluid
may move from tube 120 through the plug and thence through the
aperture into the coupling for infusion through the injection
needle. The diameter of the coupling opening adjacent to the valve
assembly and throat 126 are formed to be equal to each other and to
plug diameter 146, so that when in the dashed line position plug
138 closes off throat opening 126.
Utilizing the apparatus described above in respect of FIG. 5, when
the hollow plug is in the position shown by the solid lines,
principal fluid medicine is blocked from flowing into the coupling,
and thence through the infusion needle, while at the same time a
second fluid, such as an anti-coagulant, may flow through throat
126 into the coupling and thence into the injection needle.
Conversely, when the plug is moved to the position characterized by
the dashed lines, as explained above, principal fluid may flow
therethrough, while the second fluid is blocked off.
* * * * *