U.S. patent application number 17/544388 was filed with the patent office on 2022-03-24 for injection port protector.
The applicant listed for this patent is Icahn School of Medicine at Mount Sinai. Invention is credited to David B. Wax.
Application Number | 20220088363 17/544388 |
Document ID | / |
Family ID | 1000006013360 |
Filed Date | 2022-03-24 |
United States Patent
Application |
20220088363 |
Kind Code |
A1 |
Wax; David B. |
March 24, 2022 |
INJECTION PORT PROTECTOR
Abstract
A shielded injection port for use in an intravenous (IV)
medication delivery system includes a single piece spherical shaped
body having a hollow interior. The spherical shaped body is
truncated, at a location above a plane that passes through a center
of the spherical shaped body and defines a diameter of the
spherical shaped body, so as to define a first opening formed at a
first end of the spherical shaped body for receiving a fluid
delivery member into the hollow interior. The shielded injection
port also includes an injection port body that is integrally formed
with the spherical shaped body. The injection port body has a first
end that is contained within a bottom half of the hollow interior
of the spherical shaped body such that the spherical shaped body is
configured to surround and extend above the first end of the
injection port body.
Inventors: |
Wax; David B.; (New York,
NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Icahn School of Medicine at Mount Sinai |
New York |
NY |
US |
|
|
Family ID: |
1000006013360 |
Appl. No.: |
17/544388 |
Filed: |
December 7, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16087399 |
Sep 21, 2018 |
11207515 |
|
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PCT/US2017/024035 |
Mar 24, 2017 |
|
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17544388 |
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62313077 |
Mar 24, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2039/0205 20130101;
A61M 39/22 20130101; A61M 5/14 20130101; A61M 2039/1066 20130101;
A61M 39/20 20130101; A61M 2039/229 20130101; A61M 39/28 20130101;
A61M 39/105 20130101 |
International
Class: |
A61M 39/10 20060101
A61M039/10; A61M 5/14 20060101 A61M005/14; A61M 39/20 20060101
A61M039/20; A61M 39/22 20060101 A61M039/22 |
Claims
1. A shielded injection port for use in an intravenous (IV)
medication delivery system, the shielded injection port comprising:
a single piece spherical shaped body having a hollow interior, the
spherical shaped body being truncated, at a location above a plane
that passes through a center of the spherical shaped body and
defines a diameter of the spherical shaped body, so as to define a
first opening formed at a first end of the spherical shaped body
for receiving a fluid delivery member into the hollow interior, the
first opening having a diameter that is less than the diameter of
the spherical shaped body; and an injection port body that is
integrally formed with the spherical shaped body, the injection
port body having a first end that is contained within a bottom half
of the hollow interior of the spherical shaped body such that the
spherical shaped body is configured to surround and extend above
the first end of the injection port body, the injection port body
extending outward from a second end of the spherical shaped body in
a direction that is opposite the first end.
2. The shielded injection port of claim 1, wherein the spherical
shaped body and the injection port body are formed of a molded
plastic material.
3. The shielded injection port of claim 1, wherein the first end of
the injection port body comprises a septum that is configured to
allow a fluid from a fluid delivery device to be injected into the
injection port body.
4. The shielded injection port of claim 1, wherein the injection
port body comprises an elongated main body section with a flange at
the first end that has a diameter greater than a diameter of the
main body section.
5. The shielded injection port of claim 4, wherein the flange seats
against the second end of the spherical shaped body.
6. The shielded injection port of claim 1, wherein the injection
port body is configured to attach to a first tubing along a side of
the injection port body and attach to a second tubing at a second
end of the injection port body that is opposite the first end of
the injection port body.
7. The shielded injection port of claim 6, wherein the injection
port body and the second tubing are coaxial.
8. The shielded injection port of claim 1, wherein a length of the
injection port body that is contained within the hollow interior is
less than a length of the injection port body that lies outside the
spherical shaped body.
9. The shielded injection port of claim 1, wherein the first
opening of the spherical shaped body is located at a top edge of
the spherical shaped body and is opposite and coaxial with the
injection port body.
10. The shielded injection port of claim 1, wherein a side wall of
the spherical shaped body is curved inwardly for positioning above
the first end of the injection port body and the first opening is
positioned for placement directly above the first end of the
injection port body.
11. The shielded injection port of claim 1, wherein the plane that
passes through the center of the spherical shaped body is a
parallel to a plane that contains the entire first end of the
spherical shaped body.
12. An intravenous (IV) medication delivery system comprising: a
main line that is configured to be placed in fluid communication
with a source of fluid for delivery to a patient and terminates in
a distal end that is configured for insertion into the patient; and
the shielded injection port of claim 1, wherein the injection port
body is in fluid communication with the main line and the first end
of the injection port body has an interface that is configured to
allow a fluid from a fluid delivery device to be injected into the
main line through the injection port body.
13. The system of claim 12, wherein the fluid delivery device
comprises a syringe.
14. The system of claim 12, wherein a side wall of the spherical
shaped boy is curved inwardly above the first end of the injection
port body and the first opening is positioned directly above the
first end of the injection port body.
15. The system of claim 12, wherein the spherical shaped body and
the injection port body are formed of a molded plastic
material.
16. The system of claim 12, wherein the first end of the injection
port body comprises a septum that is configured to allow the fluid
from the fluid delivery device to be injected into the main
line.
17. The system of claim 12, wherein the injection port body
comprises an elongated main body section with a flange at the first
end that has a diameter greater than a diameter of the main body
section.
18. The system of claim 12, wherein a length of the injection port
body that is contained within the hollow interior is less than a
length of the injection port body that lies outside the spherical
shaped body.
19. The system of claim 12, wherein the first opening of the
spherical shaped body is located at a top edge of the spherical
shaped body and is opposite and coaxial with the injection port
body.
20. A method for shielding an injection port that is located along
tubing that is part of an intravenous (IV) medication delivery
system and is configured to permit injection of a fluid into the
tubing, the method comprising the step of: at least partially
encapsulating the injection port within a hollow interior of a
truncated spherical shaped protective shell such that at least a
first end of the injection port is surrounded by the truncated
spherical shaped protective shell and a top edge of the truncated
spherical shaped protective shell lies above the first end of the
injection port which lies within a bottom half of the protective
shell with the top edge of the truncated spherical shaped
protective shell defining a first opening that has a diameter less
than a maximum diameter of the truncated spherical shaped
protective shell, wherein the injection port and the truncated
spherical shaped protective shell are integrally formed with one
another to define a single part.
Description
CROSS-REFERENCE TO RELATED PATENT APPLICATIONS
[0001] This application is a continuation of U.S. Non-Provisional
application Ser. No. 16/087,399, filed Sep. 21, 2018, which is a
U.S. National Phase Application under 35 U.S.C. .sctn. 371 of
International Patent Application No. PCT/US2017/024035, filed Mar.
24, 2017, which claims the priority of U.S. Provisional Patent
Application No. 62/313,077, filed Mar. 24, 2016, each of which is
incorporated by reference as if expressly set forth in their
respective entirety herein.
TECHNICAL FIELD
[0002] The present invention generally relates to the field of
medical devices and more specifically, to devices (protectors) that
shield injection ports that are associated with intravenous
medication delivery.
BACKGROUND
[0003] Preventing healthcare associated infections has become a
major clinical and economic issue for hospitals and other similar
settings. Prior studies have linked microbial contamination of
intravenous (IV) ports and stopcocks (from practitioner, patient,
and environmental reservoirs) with postoperative infections. It is
hypothesized that these microbial contaminants gain entry to the IV
tubing, IV catheter, and eventually bloodstream and cause local or
distant infection.
[0004] Intravenous (IV) injection or infusion of medication means
that the medication is sent directly into a person's vein (arm or
hand) using a needle or tube. With IV administration, a thin
plastic tube called an IV catheter is inserted into the patient's
vein. The catheter allows the healthcare provider to give the
patient multiple safe doses of medication without needing to poke
the patient with a needle each time. IV medication is often used
because of the control it provides over a dosage. For instance, in
some situations, people must receive medication very quickly. This
includes emergencies, such as a heart attack, stroke, or poisoning.
In these instances, taking pills or liquids by mouth may not be
fast enough to get these drugs into the bloodstream of the patient.
IV administration, on the other hand, quickly sends the medication
directly into the bloodstream so that the medication can begin
working. Other times, medications may need to be given slowly but
constantly. IV administration can also be a controlled way to give
drugs over time to the patient. Certain drugs can be given by IV
administration because if the patient took the medication orally
(by mouth), enzymes in the patient' stomach or liver would break
them down. This would prevent the drugs from working well when
they're finally sent to the patient's bloodstream. Therefore, these
drugs are much more effective if sent directly into the patient's
bloodstream by IV administration.
[0005] Flow paths for gravity feeding IV solutions or infusion pump
based IV solutions to a patient are generally equipped with an
injection port through which medication (or other fluid) can be
delivered directly into the flow line for rapid administration. The
injection port typically includes a short piece of tubing that
enters the main flow line at an angle and is capped at its distal
end by a needle penetratable membrane. Modern needleless injection
ports include a port that has a retractable rubber stopper/septum
that gets pushed out of the way when a syringe is attached and then
springs back and seals the port when the syringe is removed.
[0006] Medication can also be delivered into a flow line by use of
a stopcock that assists the caretaker in controlling fluid flow
through IV delivery systems. As is generally known, a stopcock is
an externally operated valve regulating the flow of a liquid or gas
through a pipe. Stopcocks that are configured for use with IV
delivery systems include at least one injection port that can mate
with a fluid delivery device, such as a syringe.
[0007] In both types of injection ports, there is a risk that
contaminants can access the bloodstream through the injection port.
One type of contamination is contact contamination in which the
injection port contacts contaminated matter, such as skin of a
caretaker or patient, bodily fluids, bedsheets, furniture, a floor
surface, etc. In such instances, bacteria are transferred from the
contaminated surface onto the injection port. It is also possible
or less common that the contamination can arise from airborne
contaminants.
[0008] Various techniques and devices have been shown to decrease
contamination, but these are not universally practiced/used or
practical. Hand washing helps decrease practitioner contamination,
spread of pathogenic microbes to patients and devices (including IV
ports and stopcocks) they touch, and ultimately nosocomial
infections. However, compliance with frequent handwashing
recommendations is often suboptimal due to inconvenience and
intolerance. IV stopcocks are typically packaged with protective
caps but these are often removed and then never replaced (due to
inconvenience of repeated capping and uncapping), leaving the
stopcock open to contamination of the fluid path. Alcohol wipes,
scrubbing devices, and antimicrobial caps are available to
intermittently disinfect injection ports, but they are not
consistently utilized because of the time and effort they require.
They are particularly inconvenient in the operating room and
intensive care settings where frequent and/or rapid medication
administration is necessary.
[0009] The present invention overcomes the shortcomings of existing
technologies and provides barrier devices (protectors) that are
configured to prevent IV tubing port and stopcock
contamination.
SUMMARY
[0010] In accordance with the present invention, barrier devices
(protectors) are disclosed that are configured to prevent IV tubing
port and stopcock contamination.
[0011] In one embodiment, a shielded injection port for use in an
intravenous (IV) medication delivery system includes a single piece
spherical shaped body having a hollow interior. The spherical
shaped body is truncated, at a location above a plane that passes
through a center of the spherical shaped body and defines a
diameter of the spherical shaped body, so as to define a first
opening formed at a first end of the spherical shaped body for
receiving a fluid delivery member into the hollow interior. The
first opening has a diameter that is less than the diameter of the
spherical shaped body. The shielded injection port also includes an
injection port body that is integrally formed with the spherical
shaped body. The injection port body has a first end that is
contained within a bottom half of the hollow interior of the
spherical shaped body such that the spherical shaped body is
configured to surround and extend above the first end of the
injection port body. The injection port body extends outward from a
second end of the spherical shaped body in a direction that is
opposite the first end.
BRIEF DESCRIPTION OF THE DRAWING FIGURES
[0012] FIG. 1 is a schematic of an exemplary intravenous (IV)
medication delivery system having at least one inline injection
port and at least one stopcock;
[0013] FIG. 2 is a side perspective view of a device according to a
first embodiment for shielding an inline injection port to prevent
surface contamination thereof;
[0014] FIG. 3 is a side and bottom perspective view of the device
of FIG. 2;
[0015] FIG. 4 is a top and side perspective view of the device of
FIG. 2;
[0016] FIG. 5 is a transverse cross-sectional view of the device of
FIG. 2;
[0017] FIG. 6 is a top and side perspective view of the device of
FIG. 2 with the inline injection port inserted and held
therein;
[0018] FIG. 7 is a longitudinal cross-sectional view of the device
of FIG. 2 with the inline injection port inserted and held
therein;
[0019] FIG. 8 is a side perspective view of a device according to a
second embodiment for mating with a stopcock or injection port and
providing a shielded interface through which fluid can be
injected;
[0020] FIG. 9 is a longitudinal cross-sectional view of the device
of FIG. 8;
[0021] FIG. 10 is a transverse cross-sectional view of the device
of FIG. 8;
[0022] FIG. 11 is a longitudinal cross-sectional view of the device
of FIG. 8 including a movable cover which is shown in a closed
position;
[0023] FIG. 12 is a longitudinal cross-sectional view of the device
of FIG. 8 with the cover in an open position;
[0024] FIG. 13 is a side perspective view of a luer cap that is
configured to cover the interface at which fluid is delivered to
the IV system;
[0025] FIG. 14 is a side perspective view of a luer cap with a
shield that is configured to cover the interface at which fluid is
delivered to the IV system and the body of the device itself;
[0026] FIG. 15 is cross-sectional view showing a stopcock within
integral protector; and
[0027] FIG. 16 is a cross-sectional view showing an injection port
with integral protector.
DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS
[0028] FIG. 1 shows a general schematic of an exemplary intravenous
(IV) medication delivery system 10. The system 10 includes a fluid
source 20 (e.g., an IV fluid which is typically mostly formed of
water) and typically, the fluid source 20 is in the form of an IV
bag. A drip chamber 25 is located just below the IV bag 20. Inside,
the drip chamber 25, one can see the fluid drip down from the IV
bag 20 into IV tubing 30 (IV conduit in the form of flexible clear
plastic tubing). Along the IV tubing 30 includes a roller clamp 35
which is a device that is used to control the rate at which the IV
fluid infuses. If the roller clamp 35 is rolled in one direction,
the roller clamp 35 squeezes the IV tubing 30 more tightly, making
it narrower and therefore making the fluid flow through the IV
tubing 30 more slowly. Conversely, if the roller clamp 35 is rolled
in the opposite direction, the device 35 loosens its pinching of
the IV tubing 30, making the IV tubing 30 less narrow, and allowing
the IV fluid to flow through at a faster rate.
[0029] A slide clamp 40 is disposed along the IV tubing 30 and is
configured to completely stop the IV from flowing without having to
adjust the roller clamp 35. The slide clamp 40 operates by pinching
the IV tubing 30 completely shut when the IV tubing 30 is slid into
the narrowest part of the slide clamp 40.
[0030] A cannula 50 is a hollow needle, or more often a length of
flexible plastic tubing which has been inserted into the vein (arm
or hand) using a needle. The IV tubing 30 is typically taped to the
patient's arm to prevent the cannula 50 from coming out when the
patient moves. There are two different kinds of veins that can be
used for the placement of the cannula; namely, a peripheral vein,
which is any vein that is not in the torso, or a larger more
central vein in the chest. Thus, a peripheral line is an IV that is
attached to a peripheral vein (typically inserted to the arm of
hand), while a central line is an IV that is attached to a vein in
the chest.
[0031] As discussed herein, medicine or fluids other than those in
the IV bag 20 are injected into the IV tubing 30 at one or more
locations using one or more different techniques. For example, an
inline injection port, generally shown at 60 in FIG. 1, is one type
of device through which medication (or other fluid) can be
delivered directly into the IV tubing 30 for rapid administration.
Alternatively, and as shown also in FIG. 1, medication can also be
delivered into the IV tubing 30 by use of a stopcock 70 that
assists the caretaker in controlling fluid flow through IV delivery
system 10. Each of the injection port 60 and stopcock 70 is
described in more detail below. It will also be understood that the
system 10 can be configured to deliver one more medications to the
patient and thus, the system 10 can include one or more injection
ports 60 and/or one or more stopcocks 70.
[0032] Moreover, the IV delivery system 10 can also include one or
more other injection points at which fluid, such as medication, can
be injected. For example, FIG. 1 shows a secondary line 90 that is
in fluid communication with the IV tubing 30 (which represents the
main IV line) and a proximal end of the secondary line 90
terminates in a secondary injection port 91 that is configured to
mate with a fluid delivery member, such as a syringe, for injecting
fluid into the secondary line 90 and then into the IV tubing 30 for
delivery to the patient. The main line (IV tube 30) and secondary
line 90 can join one another at a catheter device 80 or the like
that allows the combined fluid to flow to the patient.
[0033] In accordance with the present invention, each access point
at which fluid (e.g., medication) is injected into the IV tubing 30
is protected against contamination (e.g., surface and/or airborne)
by a device that can be thought of as a protector. As set forth
below, depending on the type of access point (e.g., injection port
or stopcock type injection port), the construction of the device
(protector) will vary.
[0034] FIGS. 1-7 illustrate a first device (first protector) 100
according to a first embodiment and configured to shield an
injection port that is associated with intravenous medication
delivery as a means for preventing contamination of the injection
port. More specifically, the first device 100 is configured to mate
and be used with one inline injection port 60. As shown in FIGS. 1,
6 and 7, the injection port 60 can be in the form of a Y-shaped
connector that is mounted at a desired location of the flow line
(IV tubing 30) close enough to the lower or infusion end of the
line to enable the fluid injection through the port 60 to be
rapidly administered. The injection port 60 includes a main conduit
section 62 that attaches to the IV tubing 30 and an upwardly raised
arm 64 that extends radially outward from the main conduit section
62 a sufficient distance to provide ready access to a needle. The
distal end of the arm 64 is capped with a needless injection port
septum or a needle penetratable membrane 65 which can be formed of
rubber or any other suitable material that is known and used in the
art. Fluid, such as medication, is thus injected through the arm 64
into the main conduit section 62 where it joins the fluid from the
IV bag and is delivered through the IV tubing 30 to the
patient.
[0035] As mentioned herein, the illustrated device 100 is
configured to be detachably coupled to the injection port 60. The
device 100 is generally in the form of a structure that surrounds
the injection port 60 and more specifically, surrounds the port
septum 65 so as to prevent a foreign article, such as the
caretaker's hand or fingers or any other material, from contacting
the port septum 65. As discussed herein. The illustrated device 100
has a wall structure that extends above the port septum 65 so as to
prevent easy access to the port septum 65 and has only limited
access to the center of the device 100 in which the port septum 65
is located.
[0036] The device 100 can be in the form of a hollow structure that
has a hollow interior 103 in which the port septum 65 is disposed
with a wall of the device 100 surrounding and shielding the port
septum 65 from contact with foreign matter. The device 100 also is
configured to accommodate the injection port 60 in that the device
100 allows the main conduit section 62 and the arm 64 to pass
therethrough. The device 100 can thus be detachably coupled to the
injection port 60. In the illustrated embodiment, the device 100
has a generally spherical shaped body 101 with one end 102 being
truncated and defining a main entrance into the hollow interior
103. It will be understood that the body 101 can have other shapes,
such as a dodecahedron or other non-spherical shape so long as it
has a hollow interior 103. Due to the spherical shape of the device
100, the truncation at the one end 102 defines a circular shaped
opening (orifice) 105 that provides direct access to the hollow
interior 103 and in particular, is sized so as to allow insertion
of a syringe. An opposite end 104 of the body 101 also provides
access to the hollow interior 103 in that a hole 110 is formed
through the body 101. The hole 110 is formed at one end (a closed
end) of a first slot 120 that is formed in the body 101. The first
slot 120 extends from the hole 110 to the opening 105. As shown,
the dimensions of the hole 110 can be enlarged relative to a width
of the first slot 120. The hole 110 can be circular shaped and the
first slot 120 can be a continuous slot having a uniform width. The
first slot 120 receives the efferent limb of the IV tubing 30
and/or a portion of the inline injection port 60 that connects to
the efferent limb.
[0037] The body 101 also includes a second slot 130 for receiving
the afferent limb of the IV tubing 30 and/or a portion of the
inline injection port 60 that connects to the afferent limb. The
second slot 130 is formed in the body 101 at a location that is
generally opposite the first slot 120; however, it will be
appreciated that it can be formed at other locations as well to
accommodate different types of injection ports 60. The second slot
130 is defined by a circular shaped hole 131 at a closed end of the
second slot 130 and extends to the opening 105. Thus, each of the
first and second slots 120, 130 can be accessed at the opening 105
and this permits, as described herein for insertion of the
injection port 60 and the IV tubing 30. As shown, the sizes of the
hole 110 and the hole 131 can be different or in some embodiments,
the sizes can be the same. The first slot 120 has a longer length
compared to the second slot 130.
[0038] Internally within the hollow interior 103 of the body 101 is
a retaining structure that assists in holding the injection port 60
in place. For example, the retaining structure can be in the form
of first and second supports (rails or brackets) 140, 150 that
extend transversely across the body 101 and more particularly,
extends transversely along a bottom surface of the body 101. Since
the body 101 has a spherical shape, the bottom surface has a
concave shape.
[0039] The first and second supports 140, 150 can be in the form of
upstanding rails that protrude upwardly from the bottom surface.
The first and second supports 140, 150 are spaced apart from one
another and portions of the first and second supports 140, 150 are
located on opposite sides of the first slot 120. This placement
thus locates the first slot 120 centrally between the first and
second supports 140, 150.
[0040] Since the hole 110 is preferably located at the center of
spherical body 101, the center portions of the first and second
supports 140, 150 can be formed to accommodate the hole 110 which
has an enlarged shape relative to the first slot 120 as mentioned
herein. Thus, the inner surfaces of the first and second supports
140, 150 can have opposing arcuate shaped recessed portions 141,
151, respectively, so as to accommodate the injection port 60 that
is received through the hole 110. The end portions of the first and
second supports 140, 150 can be parallel to one another.
Preferably, the heights of the first and second supports 140, 150
are the same. The first and second supports 140, 150 can be
integrally formed with the body 101 as by a common molding process
when the device 100 is formed of a moldable material. In FIG. 6,
the first and second supports 140, 150 have been removed to allow
for clearer illustration of the other components and the injection
port 60.
[0041] It will be understood that the injection port 60 can
comprise a rigid plastic piece that is integral to the IV tubing
which can have a more flexible material characteristic relative to
the rigid plastic piece. It will therefore be understood that in
one embodiment, the flexible IV tubing that is attached to the
rigid plastic piece (injection port 60) can be the structures that
pass through the slots 120, 130, while the rigid plastic piece can
be contained within the body 101. Alternatively, a portion of the
rigid plastic piece may pass through the slot 120. In any event,
the slots 120, 130, permit routing of the IV tubing 30 in an inline
injection port scheme. The body 101 is then disposed over the
injection port 60 so as to surround the injection port 60.
[0042] The use of the device 100 with the injection port (an
aseptic inline injection port) 60 will be understood with reference
to FIGS. 6 and 7. The injection port 60 is disposed within the
hollow interior 103 by inserting the efferent limb of tubing (IV
tubing 30) through the first slot 120 and by pulling the injection
port 60 down through the opening 105. The injection port 60 is
disposed between the first and second supports 140, 150 so that the
injection port 60 becomes wedged therebetween. The afferent limb of
the IV tubing 30 is inserted through the second slot 130 to hold it
in place during use. The injection port 60 is held in place by the
first and second supports 140, 150, preventing twisting or
dislodgement during use, and is shielded from contact with
contaminated surfaces by the body (shell) 101. It will be
understood that the construction of the body 101 is such that the
side wall of the body 101 extends above the port septum 65 so as to
prevent lateral contact with the port septum 65. In the case of
sphere shaped body 101, the side wall not only extends above the
port septum 65 but it also has inward curvature and therefore, the
side wall extends inwardly toward the port septum 65 so as to
provide additional protective coverage of the port septum 65.
[0043] The body (shell) 101 thus at least partially encapsulates
the port septum 65 of the injection port 60. Due to the spherical
shape of the shell 101 and the location of the injection port 60
within the hollow interior 103 provides for the partial
encapsulation of the injection port 60 and therefore, it is very
difficult for a contaminated surface to come into contact with the
port septum 65 since the only point of access to the port septum 65
is through the small opening 105 that is located above the port
septum 65.
[0044] To use the injection port 60, the body (shell) 101 is
grasped in the hand and a syringe is inserted through the opening
105 and medication is injected into the injection port 60 through
the port septum 65. Grasping the body 101 positions the hand a
distance from the injection port and thus, in the case that there
is surface contamination on the hand, the contamination is
prevented from contacting the port septum 65.
[0045] In yet another embodiment, the device 100 can be an integral
part of the injection port 60 in that the device 100 is permanently
coupled to the injection port 60 and is not meant to be separated
therefrom. In other words, the shell is permanently connected to
the injection port structure such that it forms a single part that
is used with an IV line. In this embodiment as in the others, the
device 100 at least partially encapsulates the port interface of
the injection port that receives the fluid. Any number of suitable
manufacturing techniques can be used to form such a structure,
including bonding and molding techniques.
[0046] The device 100 can be formed of any number of different
materials that are suitable for the intended application described
herein. For example, the device 100 can be formed of any number of
different plastic materials that can have different degrees of
flexibility (e.g., rigid, semi-rigid, etc.). The device 100 is of
sufficient rigidity such that when the user grasps the body 101,
the body 101 maintains its shape and does not collapse so as to
cause the side wall of the body 101 to make contact with the port
septum 65.
[0047] Now turning to FIGS. 1 and 8-10 which depict a second device
(second protector) 200 in accordance with a second embodiment of
the present and intended for use with the stopcock 70. There are
many different types of stopcocks 70; however, all are configured
such that a pivotable lever 71 controls flow of fluid through the
stopcock 70 which is in fluid communication with the IV tubing 30.
In the illustrated embodiment, the stopcock 70 has main legs 72, 72
to which the IV tubing 30 is inserted so as to place the stopcock
70 in the fluid circuit. A side leg 75 is the portion of the
stopcock 70 through which the medication is delivered. The
pivotable lever 71 is manipulated so as to control delivery of
fluid from the side leg 75 into the IV tubing 30. The side leg 75
is typically in the form of a luer connector to allow for easy
connection to a syringe or the like. In the illustrated embodiment,
the side leg 75 comprises a female luer connector.
[0048] The second device 200 can be in the form of a hollow
structure that has a hollow interior 203 into which a syringe or
the like can be inserted for delivering the medication to the side
leg (e.g., female luer connector) 75 of the stopcock 70 in a manner
in which the attachment point between the fluid delivery member
(e.g., a syringe) and the second device 200 is shielded. The device
200 is configured to be detachably coupled to the stopcock 70.
[0049] In the illustrated embodiment, the second device 200 has a
generally spherical shaped body 201 with one end 202 being
truncated and defining a main entrance into the hollow interior
203. It will be understood that the body 201 can have other shapes,
such as a dodecahedron or other non-spherical shape so long as it
has a hollow interior 203. Due to the spherical shape of the device
200, the truncation at the one end 202 defines a circular shaped
opening (orifice) 205 that provides direct access to the hollow
interior 203 and in particular, is sized so as to allow insertion
of a syringe. An opposite end 204 of the body 201 also provides
access to the hollow interior 203 in that a hole or channel 210 is
formed through which fluid exits the body 201.
[0050] The body 201 includes a connector 220 that is configured to
mate with both the stopcock 70 and the fluid delivery member
(syringe). The connector 220 is located at the bottom of the body
201 and is securely coupled (attached) to the body 201 using any
number of suitable techniques including a sealed snap-fit
arrangement, use of a bonding agent, a molding process in which the
connector 220 is integral to the body 201, etc. The connector 220
can be integrally formed with the body 201 and has a first end 222
that has a first connector part 230 and at an opposite second end
224, a second connector part 240 is formed. The first connector
part 230 is disposed within the hollow interior 203 and is thus
configured to mate with the fluid delivery member, while the second
connector part 240 is disposed outside of the body (shell) 201 and
is thus configured to mate with the side leg 75 of the stopcock 70.
For example, the first connector part 230 can be in the form of a
female luer connector that is configured to mate with a distal end
(e.g., a male luer connector) of the fluid delivery member. The
second connector part 240 can be in the form of a male luer
connector that is configured to mate with a female luer connector
(side leg 75) of the stopcock 70, thereby providing a fluid
connection between the fluid delivery member (syringe) and the
stopcock 70 to allow controlled delivery of medication or the like
into the IV tubing 30.
[0051] It will also be appreciated that there are other types of
luer connectors and the connector 220 can thus be substituted with
any of these types of luer connectors.
[0052] Similar to the first device 100, the second device 200 is
configured such that the fluid entry point, in this case, the first
connector part 230 is shielded by the body 201 from contamination,
such as surface contamination. It will be understood that the
construction of the body 201 is such that the side wall of the body
201 extends above the first connector part 230 so as to prevent
lateral contact with the first connector part 230. In the case of
sphere shaped body 201, the side wall not only extends above the
first connector part 230 but it also has inward curvature and
therefore, the side wall extends inwardly toward the first
connector part 230 so as to provide additional protective coverage
of the first connector part 230.
[0053] To use the second device 200, the body 201 is grasped in the
hand and a syringe is inserted through the opening 205 and is
connected to the first connector part 230 (female luer connector).
The stopcock 70 is then opened, as by manipulating the lever, to
permit inflow from the syringe and the medication is injected into
the stopcock 70 (i.e., the side leg 75 thereof).
[0054] In yet another embodiment, the second device 200 is
configured to mate to a needless luer-lock injection port that
includes a needless septum. This type of injection port includes a
luer type connector at one end which is configured to mate to the
second connector part 240 of the device 200. Thus, device 200 is
not limited to use of stopcock constructions but can be used with
any luer type needleless injection port.
[0055] In yet another embodiment shown in FIG. 15, the device 200
can be an integral part of the stopcock 70 in that the device 200
is permanently coupled to the side leg through which medication is
injected. In this embodiment, the stopcock and shell form a single
part that is then used with the IV line. Any number of techniques
can be used to form such structure including suitable bonding and
molding operations. In this embodiment, as with the other
embodiments, the shell still at least partially encapsulates the
interface, such as a luer connector or septum, that receives fluid
from the fluid delivery device (e.g., syringe).
[0056] FIG. 16 shows another embodiment in which a device 400
(which can have the same or similar construction as the device 200)
is integral to the injection port 60 structure to form a single
piece (part). The septum 65 is located within the hollow interior
as in the embodiment of FIG. 7; however, since there are no slots,
the IV tubing 30 passes and is routed outside the shell. The shell
is thus coupled to the septum 65 and surrounds it.
[0057] Each of the first and second devices 100, 200 can be
constructed so as to include a cap or cover structure that
strategically covers either the main opening through which a
syringe is inserted to access the needle penetrable membrane as in
the case of device 100 and/or a cap or shield that covers the luer
connector of the second device 200 and/or the main opening.
[0058] The device 100, 200 can be constructed such that it includes
a cover or cap that can move between an open and closed position
relative to the opening 105, 205. FIGS. 11 and 12 show a cover 250
that is part of the device 200; however, it will be readily
understood that the cover 250 can be constructed in the same manner
with respect to the device 100 and in such case, closes off the
opening 105. The cover 250 can be constructed such that it is in
the form of the truncated portion of the spherical shell (body)
that was removed to form the opening 105, 205. The cover 250 thus
completes the sphere and has a concave bottom surface and convex
top surface as shown. It can be coupled to the remaining part of
the device 100, 200 using any number of techniques, including the
use of a hinge 255 as shown in the figures. To open the cover 250,
a lip or tab 259 is formed at one edge of the cover 250. The cover
can be spring loaded as well to ensure that it remain in a closed
position.
[0059] In one embodiment, a cover or cap can be intended to cover
at least the port septum 65 and in some embodiments, is intended to
cover the opening 105. For example, a cap can be configured to fit
over and be secured to the port septum 65 and since the cap is
intended to be placed on the port septum 65 without having to touch
the port septum 65, the cap can be disposed at a distal end of an
elongated handle. A user thus holds the cap by the handle and
inserts the cap through the opening 105 and by manipulating the
handle, the cap is placed on the port septum 65. A friction fit or
luer connection can be formed between the cap and the membrane.
[0060] As with the first device 100, the second device 200 can
include a cap or cover to shield the first connector part 230 from
contaminants, such as airborne contaminants As shown in FIG. 13, a
luer cap 300 can be configured to mate with the first connector
part 230 so as to cover and shield the first connector part 230.
Since the user is not to insert a finger(s) through the opening
205, the luer cap 300 includes an elongated handle 305 that
attaches as its distal end to the luer cap 300 and is of a length
that permits the user to insert the luer cap 300 through the
opening 205 and mate with the first connector part 230. For
example, if the first connector part 230 has threads, the handle
305 can be rotated to cause rotation of the luer cap 300 to mate
the luer cap 300 to the first connector part 230. It will be
appreciated that the luer cap 300 can be a plastic cap and/or can
contain an anti-microbial substance (e.g., Curos.TM. available from
3M).
[0061] In yet another embodiment shown in FIG. 14, the proximal end
of the handle 305 is connected to a cover 325 which is sized and
shaped to fit and close the opening 205. For example, the cover 325
can have a disk (circular) shape. The cover 325 can have a handle
330 in the form of an upstanding protrusion that can be grasped by
the user.
[0062] When the cover is designed to cover the opening 105, 205, a
recessed landing can be formed about the opening for receiving the
cover. The length of the handle is such that when the luer cap is
coupled to the first connector part 230, the cover 325 covers the
opening 205.
[0063] It will also be understood that the second device 200 can be
used with other types of needleless injection ports that have a
luer connector. For example, the system 10 can include a secondary
branch defined by a segment of IV tubing. One end of the secondary
branch terminates in a connector or the like (e.g., central
catheter) in which the main IV line is also fluidly connected. The
other end of the secondary branch terminates in a needless port
which has an exposed luer connector that is configured to mate with
the second device 200. For example, the exposed luer connector can
be a female luer connector that mates with the male luer connector
240 of the second device 200. In this way, the second device 200 is
fluidly connected to the exposed luer connector of the secondary
branch.
[0064] In at least one embodiment of the present invention, the
body of the device 100, 200 is formed so as to have an at least
substantially spherically shape with the connector being contained
in a bottom half of the body and the first opening is formed in a
top 20% of the body which is truncated so as to define the first
opening. For example, the body can be at least 70% spherical in one
embodiment, at least 75% in another, at least 80% in another and at
least 90% in yet another embodiment. However, it is possible to
truncate the sphere at other locations that are at or above the
equator of the sphere depending in part upon the overall size of
the sphere, etc.
[0065] The injection interface to which the fluid delivery member
mates for delivery fluid to the IV line is preferably located in a
bottom one half of the body of the device (protector) and can be
located in a bottom one third of the body of the device (protector)
and further can be located in a bottom one fourth of the body of
the device (protector). In general, the lower the injection
interface is located in the hollow interior of the body (shell),
the more difficult it is for contamination to occur since this
injection interface is well shielded from surface contamination and
the like. The above values are calculated based on the height of
the body as measured from the open top edge of the shell to the
bottom of the shell.
[0066] Notably, the figures and examples above are not meant to
limit the scope of the present invention to a single embodiment, as
other embodiments are possible by way of interchange of some or all
of the described or illustrated elements. Moreover, where certain
elements of the present invention can be partially or fully
implemented using known components, only those portions of such
known components that are necessary for an understanding of the
present invention are described, and detailed descriptions of other
portions of such known components are omitted so as not to obscure
the invention. In the present specification, an embodiment showing
a singular component should not necessarily be limited to other
embodiments including a plurality of the same component, and
vice-versa, unless explicitly stated otherwise herein. Moreover,
applicants do not intend for any term in the specification or
claims to be ascribed an uncommon or special meaning unless
explicitly set forth as such. Further, the present invention
encompasses present and future known equivalents to the known
components referred to herein by way of illustration.
[0067] The foregoing description of the specific embodiments will
so fully reveal the general nature of the invention that others
can, by applying knowledge within the skill of the relevant art(s)
(including the contents of the documents cited and incorporated by
reference herein), readily modify and/or adapt for various
applications such specific embodiments, without undue
experimentation, without departing from the general concept of the
present invention. Such adaptations and modifications are therefore
intended to be within the meaning and range of equivalents of the
disclosed embodiments, based on the teaching and guidance presented
herein. It is to be understood that the phraseology or terminology
herein is for the purpose of description and not of limitation,
such that the terminology or phraseology of the present
specification is to be interpreted by the skilled artisan in light
of the teachings and guidance presented herein, in combination with
the knowledge of one skilled in the relevant art(s).
[0068] While various embodiments of the present invention have been
described above, it should be understood that they have been
presented by way of example, and not limitation. It would be
apparent to one skilled in the relevant art(s) that various changes
in form and detail could be made therein without departing from the
spirit and scope of the invention. Thus, the present invention
should not be limited by any of the above-described exemplary
embodiments, but should be defined only in accordance with the
following claims and their equivalents.
* * * * *