Note: Descriptions are shown in the official language in which they were submitted.
W095/05863 21 7 n 2 3 ~ PCT~S93m8045
NEEDT~T~8 IV MEDICAL DELIVERY 8Y8TEM
I. Field of the Invention
The present invention relates generally to medical
systems for administering fluids to a patient, and more
particularly to a plurality of components incorporating an
injection site, including a preformed elastomeric, self-
sealing septum, for receiving a syringe needle or a
relatively blunt drug delivery spike.
II. Background of the Invention
The administration of fluids to a patient is typically
accomplished by inserting a catheter into a patient's vein,
and then coupling a source of fluid thereto using an
administration set including flexible tubing and one or
more couplings or fittings. Occasionally, medication is
prescribed by a physician and administered by injecting a
dosage of the medication from a syringe into the catheter.
This can be accomplished by temporarily disconnecting the
catheter from the source of fluid and then coupling the
syringe to the catheter.
Alternatively, Y-connectors are customarily
incorporated in the administration set to merge fluids from
two or more sources to a common tube and to the patient.
A typical Y-connector has a self-sealable inlet at one
branch, known as an injection site, through which the tip
of a piercing member can penetrate for injecting
medication. The source of fluid is coupled to a second
branch of the Y-connector and remains connected while
administering the medication via the first branch. These
injection sites usually include an elastomeric plug,
sometimes referred to as a "septum" to form a liquid seal.
To avoid accidental sticking while administrating a
dosage to the Y-connector, a drug transfer spike, comprised
of a cannula is typically attached to the syringe in place
of a conventional hypodermic needle. The drug transfer
spike has a blunt tip which is adapted to pierce and
penetrate the sealable inlet or septum at the injection
site. By implementing pre-slit septums in combination with
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drug transfer spikes having blunt tips, accidental
punctures which might other wise result from the use of a
st~nA~rd syringe having a sharp-tipped hypodermic needle
are avoided.
In U.S. Patent 5,199,948 to McPhee, a needleless valve
is disclosed having a pre-slit septum. The septum is held
in place in a housing inlet by a cap affixed thereabout.
The septum disclosed has a concave upper surface which
bulges and flattens when disposed in the housing inlet and
retained by the cap. A drug transfer spike is disclosed
having a ball-sh~pe~ tip, pointed enough to penetrate the
diaphragm of a drug vial, but which is not sharp enough to
puncture human skin. The McPhee injection set comprises a
total of three pieces. It does not include a locking
mech~nism for restricting accidental withdrawal of the drug
transfer spike from the septum of the injection site.
U.S. Patent 5,167,648 to Jepson et al. also teaches a
pre-slit injection site and an associated cannula. A
resealable septum is disposed in a cylindrical housing
having tapering interior walls and the outer surface of the
septum is forced into a dome-like shape due to axial forces
applied to the septum's perimeter by the housing's swaged
end members. The septum disclosed includes an elastomeric
disc with a zero-clearance slit defined axially
therethrough.
OBJECT8
It is accordingly a principle object of the present
invention to provide an improved injection site for
components used in administration sets, which will reliably
seal about a blunt tipped drug delivery pin or cannula when
pierced.
Another object of the invention is to provide in
combination an elastomeric injection site septum and a
blunt tipped drug delivery pin or cannula where the pin or
cannula includes a means for locking itself to the
injection site.
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It is a further object of the present invention to
provide an injection site comprised of a minimal number of
parts, and of parts which can be easily and inexpensively
manufactured.
Still another object of the present invention to
provide an injection site which can be incorporated into a
variety of devices including extension tubes, Y-connectors,
vial adaptors, PRN adaptors, single or multi-dose
medicament containers, blood collection tubes and fluid
source bags.
8UNMARY OF THE INV~NTION
The foregoing objects and advantages of the present
invention are achieved by a providing a injection site on
a variety of components, the injection site including a
pre-formed septum constrained within a housing inlet, and
used in combination with a drug transfer spike, the
transfer spike having a locking mech~n;sm disposed along
the length thereof for restricting retraction of the drug
transfer spike from the septum when inserted therethrough.
More specifically, the injection site comprises a
right circular cylindrical body formed from natural rubber
or a suitable elastomeric material having a pair of conic
recesses inverted relative to one another and coaxially
aligned with their apices either separated from each other
by a relatively thin membrane prior to its being pierced or
intersecting to create a small opening which becomes closed
when the body is compressed into a housing. The septum is
received and constrained within a molded plastic housing.
An elongated drug transfer spike or cannula is provided
which is adapted to be axially inserted through the septum
membrane into the housing. The drug transfer spike has a
first female Luer at one end adapted to mate with a syringe
or a male Luer on a different apparatus, an outlet port at
the other end adapted to be inserted through the conical
septum opening or membrane, and a tubular midsection with
a passageway joining the Luer fitting and the outlet port
to one another. The drug transfer spike also has a locking
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mech~n;sm disposed on a peripheral surface thereof for
restricting retraction of the drug transfer spike from the
septum when inserted therethrough. Preferably, the locking
mechanism is a positive locking member comprised of a
protrusion, preferably in the form of a ring extending
outwardly from the transfer spike at a predetermined
location. In one arrangement, this annular protrusion can
be forced through the septum to provide a tight friction
engagement therewith, wherein a substantial amount of force
is required to retract the drug transfer spike from the
injection site due to the protrusion's engagement with the
septum walls. Alternatively, the annular protrusion can be
located on the spike at a location where it will be engaged
by the plastic housing in which the septum is inserted.
The housing inlet of the injection site is comprised
of a generally cylindrical cavity defined by a plurality of
housing fingers extending thereabout. Each finger is
separated from the next by a narrow slot. Thus, each
finger can be flexed slightly outwardly to receive the
resilient septum therein during assembly. Each finger has
an inwardly extending tab at a distal end thereof to
constrain the septum within the housing inlet or recess.
In a preferred embodiment, the resilient septum has a
diameter slightly greater than the diameter of the housing
inlet and is thus compressed when inserted into the housing
inlet. Once inserted into the housing inlet, the septum
engages the inlet walls in a friction arrangement. The
height of the cylindrical cavity is such that the septum is
not axially compressed.
Other objects and features of the present invention
will become apparent to those skilled in the art through
the Description of the Preferred Embodiment, Claims, and
Drawings herein, wherein like numerals in the various
figures refer to like elements.
BRIEF DE8CRIPTION OF T~E DRAWING8
Figure 1 is an exploded elevational view in greatly
enlarged scale of an injection site contained within a
woss/0s863 PCT~S93/08045
2170237
tubular extension member adapted to receive a drug transfer
spike or cannula, which cAnnllla has a locking member or
protrusion defined therealong for restricting retraction
once inserted through the septum;
Figure 2 is a perspective view of the drug transfer
spike shown in Figure 1 further illustrating the locking
member or protrusion, and the upper portion of the spike
comprised of a female Luer lock;
Figure 3 is an end view 3-3 shown in Figure 2 further
illustrating the female Luer lock;
Figure 4 is a perspective view of the resilient septum
illustrated in Figure 1 having a pair of axially aligned,
oppositely oriented conical recesses with adjacent apices
forming a narrow opening or a membrane;
Figure 5 is a sectional view of an assembled tubular
extension body having a male Luer lock on a lower end and
a septum housing at its opposite end;
Figure 6 is a sectional view of the tubular extension
body shown in Figure 5 adapted to a catheter at a lower end
thereof, and receiving the drug transfer spike or cannula
through the resilient septum, with the locking protrusion
engaging surfaces thereof;
Figure 7 is a perspective view of a vial adaptor
which has an injection site including a septum according to
the present invention;
Figure 8 is a greatly enlarged exploded drawing
showing various devices incorporating the injection site
according to the present invention and adapted to receive
the disclosed drug transfer spike;
Figure 9 is an elevational view of the vial adaptor
shown in Figure 7 adapted to a standard Y-connector; and
Figure 10 is a side view of a blood collection tube
incorporating an injection site.
n~F~PTPTION OF THE rK~KKED EMBODIMENT
Referring now to Figure 1, an exploded view of an
injection site tube 10, termed a C-Lok, having an injection
site 11 on the proximal end thereof and a drug transfer
woss/0s863 ~ ~ 7 ~ 2 3 7 PCT~S93/08045
-6-
spike, herein termed a "key", adapted to be received
therein is shown generally at 12. Injection site 11
comprises two pieces including an elongated injection tube
14 and a resilient cylindrical septum 16 adapted to be
received in an inlet recess 18 defined at the upper or
proximal end thereof. Injection tube 14 has a tapered
lumen 20 extending axially therethrough, tapering from
recess 18 to an integrally formed male Luer lock 22. The
key 12 is adapted to mate with the tapered nose of a
syringe which is in a fluid communication with lumen 20 of
the injection tube 14.
Drug transfer spike or key 12 and housing 14 are
preferably formed of a medical grade plastic, such as a
polycarbonate. Thus, both parts can be manufactured using
conventional molding t~chn;ques and are of an inexpensive
material.
Injection tube 14 is particularly characterized in
that recess 18 is surrounded by a plurality of fingers 24
exten~;ng upwardly in the axial direction at a proximal end
thereof. Fingers 24 are defined by a plurality of equally
spaced narrow slots 26 extending in the axial direction
from the upper or proximal end of housing 14 towards its
main body. Each finger 24 is further characterized as
having a tab 28 at a proximal end thereof extending
radially inward towards the axis of injection tube 14 to
further define inlet or recess 18. Slots 26 may be
positioned at 90 intervals but limitation to four fingers
is not intended. Each finger 24 can be flexed outwardly to
receive the cylindrical resilient septum 16 in recess 18.
(See Figure 5).
Septum 16 may be made from an elastomeric material
preferably of a natural rubber material or a thermoplastic
rubber having a durometer or hardness in the range of from
10 to 70 shore A. A silicone plastic may also be used if
produced using a liquid injection molding (LIM) technique.
It has a pair of axially aligned recesses defined therein.
An upper recess 30 and the lower recess 32 each have a
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21702~7
generally conical shape and are oriented with their apices
adjacent one another. In one design, the apices are
- separated from one another by a thin membrane 34 at the
time of manufacture. Alternatively, the apices may
intersect to create a small diameter opening. Membrane 34
is adapted to be pierced when a drug transfer spike 12 is
plleh~ through it, but provides a liquid-tight seal
thereabout. (See Figure 6.) Septum 16 provides a liquid-
tight seal after drug transfer spike 12 is removed as well
due to its resilient properties. Lower conic recess 32 is
preferably larger than upper conic recess 30 to create a
tight liquid seal at the location of membrane 34 or the
preformed opening.
Referring to Figures 1 and 2, drug transfer spike 12
is comprised of a cannula with an axial passage or socket
40 defined at an upper end thereof. A tapered lumen 42
extends downwardly in the axially direction from socket or
recess 40 to a distal end 44. Socket 40 and lumen 42 are
adapted to receive a st~n~Ard syringe. More particularly,
drug transfer spike 12 includes a female Luer lock 46 as
the socket 40. The bottom wall of socket 40 creates an
annular shoulder 48 which abuts the distal nose of a
conventional syringe when disposed therein. (See Figure
6.) Drug transfer spike or key 12 is further characterized
as having a positive locking member in the form of an
annular protrusion 50 disposed at a predetermined position
along the length of the drug transfer spike 12. As will be
described below, when protrusion 50 is located
approximately midway along its length, its rounded surface
restricts retraction of the drug transfer spike 12 from the
injection site 10 when the spike has been inserted through
the membrane 34 so as to engage the side walls defining the
conic recess 32. In an alternative arrangement, the
annular protuberance is located a short distance from the
bottom of the female Luer, as at 35 in Figure 1, so as to
interact with the finger tabs 28 to provide a locking
detent.
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217~2~7
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Figure 3 is included to show an end view of drug
transfer spike or key 12 and revealing the concentric
features thereof.
Referring to Figure 4, a perspective view of the
elastomeric septum 16 is shown, illustrating the upper
conical recess 30 and the lower conical recess 32 in
phantom lines. As shown, septum 16 has narrow annular rims
33 and 35 defined at each end encompassing the respective
recesses.
Referring now to Figure 5, an assembled C-Lok 10 is
shown with a septum 16 disposed within its 18. By way of
example and without limitation septum 16 may have a
diameter of approximately .250 inches which is slightly
greater than the diameter of recess 18, which may be, for
example, .216 inches. Thus, when installed as shown,
resilient septum 16 is radially compressed slightly and
thus elongated slightly in the axial direction.
Cylindrical recess 18 has a height dimension H, wherein H
may be approximately .296 inches. When installed in recess
18, septum 16 occupies generally 75~ of that recess 18 by
volume. Recess 18 has a generally cylindrical wall which
extends downwardly to an annular shoulder 56. As shown,
tapered passageway 20 tapers downwardly in the axial
direction from shoulder 56 to an annular shoulder 58.
Passageway 20 tapers downwardly from shoulder 58 to a lower
port 60 forming a portion of male Luer lock 22.
Figure 6 illustrates a sectional assembled view of
injection site or C-Lok 10 and its housing 14 receiving
drug transfer spike or key 12. A standard tubular catheter
62 is shown coupled to the male Luer lock 22, and a
st~n~rd syringe 64 has its tapered nose disposed within
conforming socket or recess 40 and passageway 42 of key 12.
As shown, key 12 is inserted through membrane 34 of septum
16 such that positive locking member or protrusion 50 is
disposed through the opening made through membrane 34 of
septum 16 and frictionally engages the sloping surfaces of
lower recess 32. Annular protrusion 50 inhibits the
woss/05863 PCT~S93/08045
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g
accidental or inadvertent retraction of drug transfer spike
12 from injection site 10.
- When key 12 is inserted into injection site or C-Lok
10, septum 16 is further compressed in the radial direction
such that septum 16 becomes even more elongated in the
axial direction, as shown. Septum 16, however, still
remains slightly spaced above shoulder 56 such that it is
not axially compressed. As shown, because of its resilient
properties, septum 16 maintains a liquid-tight seal about
the key 12 for inhibiting leakage of medication from
passageway 20. A substantial portion of housing passageway
20 remains unoccupied by the lower end of drug transfer
spike 12, which unoccupied area can be utilized to receive
a filter element if desired. Such a filter will prevent
any particles scraped from the elastomeric septum from
entering a patient.
In use, after a dose of medication has been withdrawn
from a multiple dose or single dose vial, it can be ejected
from syringe 64 into C-Lok 10, via injection site 11.
Spike 12 and syringe 64 may then be retracted in the axial
direction, either individually or together, from septum 16.
Septum 16, being resilient, will return to its normal
shape, shown in Figure 5, such that a liquid-tight seal is
again maintained by septum 16. Inwardly extending tabs 28
of fingers 24 constrain and restrict septum 16 from
becoming dislodged while the drug transfer spike or key 12
is pulled out of the septum 16.
Referring now to Figure 7, a perspective view of a
Key-Loc adaptor 92 is shown. The Key-Loc adapter is a
single-patient, multi-use adapter device for gaining
entrance to non-prepierced or self-sealing membranes,
including elastomeric injection sites on intravenous tubing
sets, the injection site on IV fluid bags and the membrane
on single-dose and multi-dose medicament vials and the
blood collection tubes/containers. Figure 9 shows the Key-
Loc adaptor 92 operatively coupled to a standard Y-
connector 93 where a notch 100 in the shroud 101
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--10--
accommodates one of thè Y branches 103. The notch 100
extends from the edge of the cylindrical outer wall in the
axial direction and is adapted to receive one of the Y
branches. A stainless steel hypodermic needle 102 (Figure
7) is concentrically disposed within the skirt or shroud
101 of the adaptor and recessed from its edge so as to be
shielded to prevent accidental sticks of medical personnel
who may handle it. In this configuration, adaptor 92 is
adapted to receive a syringe and drug transfer spike or key
at injection site 94.
A modified Y-connector is shown at 70 (Figure 8)
having a main branch 72 connected to an IV line 73 and a
pair of bifurcated branches 74 and 76. Branch 74 is also
coupled to an IV line 75. The branch 76 is aligned with
the main branch 72 and has an injection site 80 similar in
design to the upper end 11 of C-Lok 10 illustrated in
Figures 1, 5 and 6. Specifically, injection site 80
includes a plurality of fingers 82 each having a septum
retaining tab 84 extending radially inward, similar to
fingers 24 and tabs 28 shown in Figure 1. An inlet recess
or socket 86 is formed at the proximal end of branch 76 for
receiving a cylindrical, molded septum 16. Septum 16 and
recess 86 may have the same dimensions as septum 16 and
recess 18 previously described in reference to Figure 1.
Thus, key 12 can be locked to injection site 80 in either
of the ways previously described in reference to Figure 6.
Still referring to Figure 8, yet another feature of
the present invention is shown. Here, the adaptor,
indicated generally by numeral 92 has an injection site 94
similar to injection site 11 shown in Figure 1. Adaptor 92
can be used with either a multi-dose vial 96 of medicant as
is indicated by dashed lines 97, as shown, or to a single
dose vial (not shown). A multi-dose vial may incorporate
a conventional rubber barrier 98. Barrier 98 of vial 96 is
disc-shaped and also comprised of a resilient natural or
synthetic rubber material of a predetermined durometer.
Septum 98 is adapted to be placed upon the rim of vial 96
W095/05863 PCT~S93/08045
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and secured thereto using an industry standard aluminum
seal ring 100. Adaptor 92 has a sharpened metal needle 102
- with a lumen 104 axially exten~;ng therethrough.
Needle 102 is adapted to penetrate through septum 98,
or a stAn~Ard rubber seal 105 of IV bag 106 as indicated by
the dashed lines 99 in Figure 8. Alternatively, Key-Lok
adaptor 92 can be used in combination with a key 12 to
couple syringe 64 to a st~n~rd IV fluid bag, shown at 106.
In yet another arrangement, the syringe 64 and spike
12 may be used to enter a single or multi-does vial 108 if
this vial is provided with an elastomeric barrier 110
having the inverted conical recesses similar to those on
the septum of an injection site, making it unnecessary to
use adaptor 92 to load the syringe.
Thus, as shown in Figure 8, the drug transfer spike or
key 12, according to the preferred embodiment of the
present invention, can be used to penetrate an injection
site on a C-Lok 10 to inject a medicant from syringe 64
into a stAn~rd catheter, as in Figure 6, or to an adaptor
92 when drawing the medicant into the syringe 64. It is
also contemplated that the injection site 11 can be formed
on a blood collection vial or tube 111. Such an
arrangement is shown in Figure 10.
While an annular ridge 50 with a smoothly rounded
outer surface is the preferred way of forming the locking
member, it is also recognized that one or more protrusions
having other shapes defined at a predetermined location on
key 12 can be used as well. Further, while a positive lock
is preferred, such as a protrusion, it is also recognized
an annular recess on the shaft of cannula 50 can be made to
coact with a mating projection within the lumen of the
tubular member into which it is inserted. An annular
recess in the spike has the disadvantage of possibly
weakening it, however.
Further, it is also to be recognized that while a pair
of conical recesses are the preferred design for septum 16,
the recesses could have identical or different shapes and
W095/05863 PCT~S93/0804S
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-12-
sizes, and limitation to the upper recess having a volume
less than the volume of the lower recess is not to be
inferred.
In summary, an injection site comprised of only two
pieces is disclosed. It offers the advantage of being
ineY~ncive to manufacture and assemble. The injection
site can be adapted to a variety of devices including
extension tubes, vial adaptors, Y-connectors, PRN adaptors,
single or multi-use medicament containers, blood collection
tubes and fluid source bags as well as blood collection
tubes. The positive locking member defined along the
length of drug transfer spike or key 12 inhibits its
accidental retraction, such as by patient movement, while
a drug is being injected into a fluid line leading to an
indwelling catheter. The uniquely designed septum provides
an efficient resealable opening, which opening may be
adapted to engage a protrusion 50 on the key to provide a
locking arrangement. Finally, the resilient fingers of the
injection site facilitate retaining septum 16, yet allowing
easy insertion of septum 16 therein. No separate cap is
required for securing septum 16 therewithin as in other
prior art arrangements.
This invention has been described herein in
considerable detail in order to comply with the Patent
Statutes and to provide those skilled in the art with the
information needed to apply the novel principles and to
construct and use such specialized components as are
required. However, it is to be understood that the
invention can be carried out by specifically different
equipment and devices, and that various modifications, both
as to the equipment details and operating procedures, can
be accomplished without departing from the scope of the
invention itself.
