Valves and valve actuation – With correlated flow path – Valve operated by joining flow path sections
Reexamination Certificate
2000-05-09
2001-10-09
Shaver, Kevin (Department: 3754)
Valves and valve actuation
With correlated flow path
Valve operated by joining flow path sections
C604S905000
Reexamination Certificate
active
06299131
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to medical IV administration line connectors. More particularly, this invention relates to needleless injection ports for the safe infusion and/or aspiration of fluids in intravenous and blood administration therapy.
2. State of the Art
Intravenous therapy has a long history of use in supplying patients with pharmaceuticals, liquid nourishment, or blood products. Prior art
FIGS. 1 through 4
show that the current or conventional way of introducing parenteral liquid solutions and/or blood and blood products into a patient is by the conventional gravity feeding system
10
. The feeding system
10
includes a container
12
that is either a bottle or bag for the parenteral solution, a tube
14
extending from the bottle or bag and connected to a Y-injection site
16
(piggyback or secondary Y-injection site), and a tube
18
from the Y-injection site
16
to a needle or catheter
20
which is inserted into a vein in the arm
22
of the patient. The vein-access needle or catheter is taped to the patient with adhesive tape
24
so that the chance of a detachment and disconnect from the vein is minimized.
Supplemental intravenous therapy from a piggyback or secondary bottle or bag
26
is introduced through the Y-injection site
16
into the primary intravenous administration set
10
. As seen best in
FIG. 3
, the Y-injection site
16
which is integrated into the primary intravenous administration set
10
consists of two tubular conduits
16
a,
16
b
which merge into a third tubular conduit
16
c.
The tubing
12
from the bottle or bag of parenteral solution of the primary intravenous administration set
10
is attached into the inlet port
16
a
of the Y-injection site. In similar fashion, the tube
18
is attached into the exit port
16
c
of the Y-injection site. A sealed entry port segment
17
of the Y-injection site
16
is provided by the extension conduit
16
b
which has a standard self-sealing latex rubber septum
17
a
at its inlet port to seal this port from leakage. Consequently, it is difficult for pathogens to enter the Y-injection site
16
via the septum port
17
because of the seal
17
a.
This self-sealing septum
17
a
is of a conventional design and includes coaxial annular aprons which fit over the conduit wall and grip the external and internal wall surfaces to hold the septum securely to the conduit
16
b.
Typically, a plastic shrink-band (not shown) is shrunk on the outer wall of the septum
17
a
to securely connect it to the extension conduit
16
b.
The supplemental intravenous solution is introduced into the primary intravenous administration set
10
through the Y-injection site
16
by way of a primed piggyback or secondary intravenous set
26
. The piggyback or secondary intravenous set
26
has a hollow-bore needle
28
attached to its distal end, which in turn is inserted through the self-sealing septum
17
a
of the Y-injection site
16
and into the extension conduit
16
b.
This needle
28
is connected to a tube
30
which is connected to a drip-chamber (not shown) of the piggyback or secondary intravenous set
26
. A roller clamp
14
a,
30
a
is typically used on both the primary and piggyback/secondary intravenous sets to control liquid flow rates into the patient.
There are several problems associated with the standard techniques employed for intravenous therapy. If the piggyback needle
28
is not securely taped to the Y-injection site
16
and the primary intravenous administration set tubing
12
,
18
, patients can move their arms, or roll over in bed accidentally pulling the needle
28
completely out of the septum
17
a
on the Y-injection site
16
. If this occurs, the self-sealing latex septum
17
a
will close off automatically and not allow liquid or contamination to enter the primary intravenous administration set
10
. The primary intravenous solution in the bottle or bag
12
will continue to flow into the patient, but, the necessary supplemental pharmaceutical solution from the piggyback or secondary bottle or bag
26
will no longer flow into the patient via the Y-injection site
16
. The consequences to the patient for this situation can lead to serious complications and even death if the condition is not noticed by a clinician immediately. Even if the clinician notices the detachment of the needle
28
from the Y-injection site septum
17
a
immediately, the needle
28
is now contaminated with pathogens and should never be introduced back into the septum
17
a.
A new sterile, piggyback/secondary intravenous set must be opened, primed, and a new hollow-bore needle reinserted back into the septum on the Y-injection site. Additionally, whether the needle
28
is accidentally detached, or, the clinician removes the needle
28
from the Y-injection site septum once the supplemental pharmaceutical therapy is completed for the patient, the exposed needle
28
is contaminated with pathogens and must be safely disposed by the clinicians without accidentally sticking themselves.
To avoid accidental removal, the needle of the piggyback or secondary intravenous set may be taped to the Y-injection site and extension port. When this occurs, the needle may be secured from detachment, but the needle cannot be easily and safely removed by the clinician when the supplemental pharmaceutical therapy is completed, thereby creating a higher incidence for an accidental needle stick injury. Also, because clinicians hold the Y-injection site with one hand while the other hand is used to insert the needle into the Y-injection site septum, the clinicians may accidentally stick the needle directly into their hands holding the Y-injection site, or stick the needle completely through the Y-injection site wall into their hands.
The above description and problems associated with conventional continuous and supplemental intravenous therapy through a Y-injection site is similar to the problems associated with intermittent intravenous therapy using a “Heparin Lock” injection port
40
(FIGS.
2
and
4
). A heparin lock injection port
40
is either connected directly to the vein-access device
20
, or attached to a short catheter extension tubing set
42
typically with microbore tubing which is attached to the vein-access device as shown in FIG.
2
. The heparin lock has a self-sealing septum port
44
which is similar to the septum port
17
described above. A conventional intermittent intravenous therapy could utilize a short-term primary intravenous administration set
26
with a hollow-bore needle
28
attached to the distal end of a tube
30
. The needle would be inserted to the self-sealing septum found on standard heparin lock injection port
40
. Another means of introducing supplemental intermittent pharmaceuticals to a patient is to perform an intravenous push utilizing a syringe with a hollow-bore needle attached. The drug is pushed into the patient through the heparin lock injection port
40
. Once dispensed, the syringe/contaminated needle is removed from the self-sealing septum
44
on the heparin lock injection port
40
.
As set out above, the common medical techniques for delivering supplemental liquid fluids to the patient necessitates the use of a hollow-bore needle. The needle is either attached to a secondary intravenous set or a syringe, and is inserted through the self-sealing rubber stopper on the heparin lock injection port or the Y-injection port that is integrated into the primary intravenous administration set. Typically, the needle is secured to the injection port only with tape. The needle can detach from the injection port resulting in a serious or fatal interruption of the flow of the intravenous solutions to the patient. Moreover, the exposed needle can easily be contaminated by contact with non-sterile objects. Sound aseptic techniques must be practiced by the healthcare professional in order to ensure that the sterile needle does not become contaminated and cause a nosocomial infection to the patient.
Since the discovery of the HIV virus
Gallagher Thomas A
Gordon David P.
Jacobson David S
Keasel Eric
Rymed Technologies, Inc.
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