Note: Descriptions are shown in the official language in which they were submitted.
The present invention relates to I.V.
administration systems, and more particularl~, to
piercing pins usable in both vented and unvented I.V.
administration systems using rigid and fle~ le
containers respectively.
Liquids, such as amino acids, blood, de~trose,
electrolytes, and saline are usually adrninistered to
patients over a prolonged period of time through an I.V.
administration set. Generally, these I.~J.
administration sets employ a rigi~ container such as a
glass bottle or a fle~ible container such as a plastic
bag to store the liquid which is to be -fed intravenously
to the patient. An example of such sets is an I.V.
administration set marketed under the trade name
Venoset, by Abbott Laboratories. Similar systems are
disclosed in U.S. Patent 3,886,937 to Bobo, et al.; and
U.S. Patent 4,105,029 to Virag.
One of the problems with I.V. administration
sets employing rigid containers is that in order to
dispense liquids from a rigid container, air must be
drawn into the container as liquid flows from the
container. Accordingly, venting mechanisms are empLoye~
which allow for the entrance of air into the rigid
liquid container as the liquid is being withdrawn. ~he
conventional means of venting a rigid container is
through a vented piercing pin whicih is inserted through
the puncturable closure normally used to seal the rigid
medical liquid container.
To avoid the necessity of venting the container
of I.V. fluid and to reduce the cost of the system, a
recent innovation in I.V. administration systems has
been the use of blow-molded, collapsible, fle~ible
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containers to dispense lir~ui-ls. These containers lo not
require venting, as the sides of the container col'apse
as the liquid supply is depleted. ~n eY.am~le of such
containers may be found in U.S. Patent ~o. 4,2~,409
assigned to Abbott Laboratories.
A problem has arisen, nowever, in tihe
manufacture of equipment sets in ~eneral and in the
manufacture of piercing pins in partlcular.
Specifically, different piercins pins must be used for
vented systems employing rigid con'ainers and unvented
systems whicn employ flexible containers. It has been
found that on some occasions, vented piercins pins have
been used with flexible containers which results in the
risk that air may be passed th~ough the I~V.
administration system to the patient. Converselv, in
some instances, unvented piercing pins have been used
with rigid containers, thereby rendering the vented
system employing the rigid container inoperative because
air is not allowed to flow into the container in place
of dispensed fluid. One attempt to solve the venting
problem for rigid containers may be seen in U.S. Patent
NoO 3,662,752 to Yokoyama. The close proximity of the
openings for air and fluid in the device disclosed in
this patent render it unusable with flexible containers
as the design of the piercing pin between its tip and
the air vent would not allow it to be re~ained in tne
closure of a flexible container.
It is, therefore, an advantage o~ the present
invention to provide a universal piercing pin which ma~
be used in both vented and unvented l.V. administration
systems. It is an additional advantage of the present
invention to provide a piercing pin in which the ventiny
of an I.V. administration system may be selectivel~
actuated.
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According to the present lnventlon there i5
provided a piercing pin for providlng fluid communication
with tne interior of a rlgicl or flexible liquid container,
the pin having a substantially longitudinal spike member
adapted for the flow of liquid having a piercing tip at
one end. A lumen extends through the splke member having
a first and second opening at either end of the lumerl,
the first opening being operatively positioned proximate
the piercing tip and the second opening being spaced from
the piercing tip~ At least one fluid passage is positioned
exteriorly of the spike member and having a first port and
a second port, the first port being spaced inwardly from
the first lumen opening. At least one of the fluid passage
members is adapted for the flow of air. A hydrophobic
membrane is operatively positioned within the fluid passage
and is adapted for the flow of air. When the piercing pin
is used with a rigid liquid container, the first port of the
fluid passage is positioned in fluid communication with the
inside of the rigid container and the spike member provides
a path for the flow of liquid out of the rigid liquid
container through the first opening, the lumen and the
second opening, and the fluid passage provides a path
for the flow of air into the rigid liquid container through
the second port, the fluid passage and the first port.
When the piercing pin is used with a flexible container
the first port of the air passage is positioned out of
fluid communication with the inside of the flexible liquid
container and the spike member provides a path for the
flow of liquid out of the flexible liquid container through
the first opening, the lumen and the second opening.
In a specific embodiment of the invention the
hydrophobic membrane is positioned in the second port of
the fluid passage.
More specifically, there may be provided a plurality
of fluid passagesO
A rubber reseal may be operatively positioned
in a second port of one fluid passage and a hydrophobic
member is positioned in another second port of the fluid
passage.
Brief ~e~.cription of tlle Drawinqs
~ better understandirlg of tlle device of the
present inventiorl may be had by reference to the
drawings wherein:
FIGURE 1 of the clrawings is a front view of a
vented I.V. administration set employing a rigid
container and the improved universal piercing pin of
this invention.
FIGURE 2 of the drawings is a front -~iew of an
unvented I.V. administration set employing a flexible
container and the improved universal piercing pin of
this invention~
FIG~RE 3 is a vertical sec~ion oE the improved
universal piercing pin of tnis invention.
FIGURE 4 of the drawings is a cross-sectional
view taken along line 4-4 OL FIGURE 3~
FIGURE 5 of the drawings is a vertical section
of the improved universal piercing pin of this invention
in the port of a rigid container.
FIG~RE 6 of the drawinc3s is a vertical section
of the improved universal piercing pin of this invention
in the port of a fle~ible container.
Detailed Description of the Preferred ~mbodiment
While this invention is susceptible of man~
embodiments in many different forms, there is shol/n in
the drawings and will be herein described the preferred
embodiment, with the unders-tanding that the preferrec~
embodiment illustrated hereitl is an e~emplificati~ll of
the principles of the invention and is not intended to
limit the invention to the preferred eml~odiment
illustrated.
As best seen in FIGURE 1 of the drai~ings,
vented I.V. administration set generally L0 has a rigid
medical liquid container 11 with a resilient,
resealable, penetrable sealing member 12 at container
opening 13. Extending through resilient, penetrable
sealing member 12 is the device of this invention,
piercing pin generally 30, which in this case has a drip
~ ¢~3
chamber 16 attached theret:o. E,Yten~irlg frorr, dri~
chamber 16 is a l.ength of ~lexi~le tuhing 17, upon lhich
is affixed a roller clamp 18, and an on/ofE sli-le clarnp
27 for contr~Lli.ng the flow of medical liqui~i 19 frorn
container 11. At the opposite end of flexibLe tubing 17
is a hypodermic needle 20, which is inserted into t~e
arm of a patient Eor the administration of medical
liquid 19~
As further seen in FI~-U~E 2 of the dra~ gs, an
unvented I.V. administration system, generally 21, ihas a
collapsible medical liquid container 22 with a resilient
rubber reseal 23 affi~ed at container end 24. ~xtendin~
through resilient rubber reseal 23 is the device of this
invention piercing pin 30. Extending from piercina pin
25 is a drip chamher 25 which may be used to count the
number of drops per minute and thereby determine the
rate of flow of medical liquid 19 from container 22.
Extending from drip chamber 26 is a length of fle~ible
tubing 17, on whicll is mounted a roller clamp 1~, an
on/off slide clamp 27, and a hypodermic syringe 20.
The construction of the improved universal
piercing pin of this invention is best seen in FIGURES 3
and 4. Specifically, the device of this invention
consists of a spike member 32 having a substantially
longitudinal lumen 36 running therethrough. The snike
member terminates at a piercing tip 34 which is adaptecl
for penetration oE a punc~urable sealing member roun~ in
either ri~3id container 11 (FIGURE 1) or Elexible
container 22 (FIGUR~ 2). The ll~men 3~ runnin~3 throuah
spike member 32 begins at first opening 40 and ends at
second opening 48. Supportinc3 spike member 32 is a oase
flange 52. Furtner support for spike member 32 is
provided by ring 54 which, in the preferred embodiment,
is shown as having a substantially triangular cross
section. Located on the e~ternal sur~ace oE piercing
_. 5 _
, ....
pin 32 are fluid passages 3B which are ~orme~1 b~ the
presence of an oversllroud 50 formed aroun~l spike~ mernber
32. The fluid passages 38 exten~3 from first port ~ to
second port 43. Shown positioned at the second port 43
of one flui~ passage 38 is hy~lrophobic membrane ~4.
Shown positioned in another fluid passage 3~ is an
optional rubber reseal 45. Overshroud 50 is maintained
in place by frictional interfitment 51 over spi~.e ~ember
32.
Operation
The operation of the universal piercing pin 30
of this invention is best seen in FIGURES 5 and 6.
In FIGURE 5, pin 30 is sho~n as protrudin?
through resilient, resealable, penetaDle sealing member
12 to point 45. The insertion o-F piercing pin 30 into
resilient, resealable, penetrable sealing memDer 12 to
point 45 causes lumen 36 to be in fluid communica~ion
with the liquid contained within the I.V. container,
thus allo~ing the liquid to pass through fluid passage
36 from first ~pening 40 to second opening 48. As the
fluid flows out of the container, air must replace .he
displaced fluid. This air is supplied to the container
by first passing tllrough hydrop11obic me~brane 44 in port
43, then through passage 3~ aild finall~ throu(3h secon-l
port 42 into the container.
In FIGUR~ Z, it is shown that the same improved
piercing pin 30 used with the port o~ a rigi~ container
(FIGURE 5) may also he used in the por-t of a fle~i~le
container. Specifically, piercing pin 30 is inserted
through protective cap 7~ so that opening 40 is in --lui~
communication with the liquid witnin the fle~ible
container. Rather than being inserted through resilient
rubber reseal 23 to point 45 as ~ith the rigi,-l container
(FIGUR~ 5), improved piercing pin 30 is inserted o~
partway through reseal 23 so as to Leave first port 42
out~ide the container of I.V. solution. In this ~ay,
air does not pass throu~h hydrophobic membrane 44 to the
inside oL the container, but I.V. flui~ may pass from
the interior of the flexible container through first
opening 40, lumen 36 and out second openin~ 4~ in~o the
l.V. administration system (not above).
The preferred material for fabrication of the
improved universal piercing pin 30 is rigid
polyvinylchloride. However, other plastic materials
such as polycarbonate, ~BS, or styrene could be
utilized. Inserted within second port 43 is a
hydrophobic membrane 44 as previously stated.
Optionally, inserted within one fluid passage 38 is
rubber reseal 46 which allows for the temporary
insertion oE a cannula or hypodermic needle to add
medicament to or extract samples from the I.V.
ad~inistration system.
It will tnus be seen that through the present
invention there is now provided a improved universal
piercing pin for both vented and nonvented I.V.
administration sets wherein rapid connection and
disconnection may be made with a source of I.V. fluid.
The improved universal piercing pin of this invention
can be readily molded and fabricated at little cost so
as not to appreciably add to the cost of a complete I.~v7.
administration set~
The foregoing invention can now be practiced 'oy
those skilled in the art. Such skilled persons will
know that the invention is not necessarily restricted to
the particular embodiments presented herein. The scope
of the invention is to be defined by the terms of the
following claims, as given meaning by the precedin~
description.
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