U.S. patent application number 14/283449 was filed with the patent office on 2014-09-11 for connector for fluid conduit with integrated luer access port.
This patent application is currently assigned to Medline Industries, Inc.. The applicant listed for this patent is Medline Industries, Inc.. Invention is credited to James E. Burgess, John H. Kutsch.
Application Number | 20140250664 14/283449 |
Document ID | / |
Family ID | 43823761 |
Filed Date | 2014-09-11 |
United States Patent
Application |
20140250664 |
Kind Code |
A1 |
Burgess; James E. ; et
al. |
September 11, 2014 |
Connector for Fluid Conduit with Integrated Luer Access Port
Abstract
A connector (900) for fluid conduit includes a connector body
(901) having a lumen (902) passing along a longitudinal axis (903),
and a luer access port (800) extending distally along a transverse
axis (905). The luer access port (800) is made from a thermoplastic
elastomer (500) having a domed interior portion (501) and a
stair-stepped perimeter (502) that is coupled to a cylindrical wall
(600). The thermoplastic elastomer (500) and cylindrical wall (600)
can be integrally coupled in an insert molding process.
Inventors: |
Burgess; James E.;
(Mundelein, IL) ; Kutsch; John H.; (Harvard,
IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medline Industries, Inc. |
Mundelein |
IL |
US |
|
|
Assignee: |
Medline Industries, Inc.
Mundelein
IL
|
Family ID: |
43823761 |
Appl. No.: |
14/283449 |
Filed: |
May 21, 2014 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
12572708 |
Oct 2, 2009 |
8764731 |
|
|
14283449 |
|
|
|
|
Current U.S.
Class: |
29/428 ;
264/255 |
Current CPC
Class: |
Y10T 29/49826 20150115;
A61M 2207/00 20130101; A61M 2039/1033 20130101; A61M 39/10
20130101; A61M 2039/1027 20130101; A61M 39/1011 20130101; A61M
2039/1083 20130101; A61M 2039/1072 20130101; B29C 45/1676
20130101 |
Class at
Publication: |
29/428 ;
264/255 |
International
Class: |
A61M 39/10 20060101
A61M039/10 |
Claims
1. A method of manufacturing a luer access port with an insert
molding process, comprising: forming a first portion of the luer
access port in a mold by injecting a first material into a cavity
of the mold; the first portion comprising one of a stair-stepped
elastomer membrane or a luer access port body; removing at least
one tooling component from the cavity, thereby creating additional
cavity space; and forming a second portion of the luer access port
by injecting a second material into the cavity about the
stair-stepped elastomer membrane to form the luer access port; the
second portion comprising another of the stair-stepped elastomer
membrane or the luer access port body; and the first material
comprising one of an elastomer or a thermoplastic, and the second
material comprising another of the elastomer or the
thermoplastic.
2. The method of claim 1, further comprising: providing a connector
body having a first lumen extending along a longitudinal axis and a
second lumen extending along a transverse axis and intersecting the
first lumen; and coupling the luer access port to the connector
body about the transverse axis.
3. The method of claim 2, further comprising cutting an incision in
the elastomer.
4. The method of claim 2, the providing further comprising
providing a tubular connection member having the first lumen
passing therethrough.
5. The method of claim 4, the tubular connection member further
comprising a male conduit connector and a female conduit receiver,
the luer access port coupled to a waist of the tubular connection
member disposed between two side portions, the two side portions
each having a height greater than the waist.
6. The method of claim 5, the height of a highest of the two side
portions greater or equal to a waist height of the waist, plus a
port height of the luer access port.
7. The method of claim 5, one or more of the waist and the two side
portions having a cross-sectional shape that is
non-cylindrical.
8. The method of claim 6, the waist having a waist width that is
greater than the waist height.
9. The method of claim 8, wherein the waist width less than or
equal to 0.250 inches, the waist height less than or equal to 0.200
inches, and the port height less than or equal to 0.200 inches.
10. The method of claim 5, a surface area spanning the waist and
the two side portions is smooth.
11. The method of claim 5, the waist and two side portions defining
a port support region having an hourglass appearance.
Description
CROSS REFERENCE TO PRIOR APPLICATIONS
[0001] This application is a divisional of U.S. application Ser.
No. 12/572,708, filed Oct. 2, 2009, which is incorporated by
reference for all purposes.
BACKGROUND
[0002] 1. Technical Field
[0003] This invention relates generally to a connector for fluid
conduit, including tubing or hose, and more particularly to a
connector having a port by which the luer of a syringe may take
samples of fluid passing though the connector.
[0004] 2. Background Art
[0005] A "luer" connector is a feature found on many syringes that
facilitates a leak-free connection being made between the needle
hub and a corresponding fitting. For example, a health care
provider may purchase syringes and hypodermic needles separately.
It is often the case that the hypodermic needle will include a
female adaptor coupled thereto for mating with a syringe. This
female adaptor slides over a male needle hub. To ensure that a
leak-free seal is formed, a luer connector may be disposed about
the needle hub. The luer connector generally looks something like a
cylinder disposed about the needle hub. The luer connector may
include a locking mechanism, such as threads, or may be a "slip"
luer without locking mechanisms.
[0006] In fluid collection or extraction procedures, such as those
involving an intravenous device or a catheter, it is often
necessary to take a sample of the fluid passing through the fluid
conduit, which is often rubber tubing or a similar material. This
can be accomplished by coupling a hypodermic needle to a syringe
and inserting the needle into the tubing to draw the sample. This
process is problematic, however, in that some fluid conduit can be
quite narrow, which makes it easy to pass the hypodermic needle
completely through the conduit.
[0007] There is thus a need for an improved device suited for
facilitating sampling of fluids from fluid conduit that is simple
to manufacture, cost effective, and reliable.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 illustrates a perspective view of one tubular
connection member connector body in accordance with embodiments of
the invention.
[0009] FIG. 2 illustrates a sectional view of one tubular
connection member connector body in accordance with embodiments of
the invention.
[0010] FIG. 3 illustrates a side, elevation view of one tubular
connection member connector body in accordance with embodiments of
the invention.
[0011] FIG. 4 illustrates a top, plan view of one tubular
connection member connector body in accordance with embodiments of
the invention.
[0012] FIG. 5 illustrates a perspective view of a thermoplastic
elastomer in accordance with embodiments of the invention.
[0013] FIG. 6 illustrates a perspective view of a luer port
cylindrical wall in accordance with embodiments of the
invention.
[0014] FIG. 7 illustrates a sectional view of a luer port in
accordance with embodiments of the invention.
[0015] FIG. 8 illustrates a perspective view of a luer port with a
slit thermoplastic elastomer in accordance with embodiments of the
invention.
[0016] FIG. 9 illustrates a sectional view of a connection member
having a luer port coupled thereto in accordance with embodiments
of the invention.
[0017] FIG. 10 illustrates a perspective view of a connection
member having a luer port coupled thereto in accordance with
embodiments of the invention.
[0018] FIG. 11 illustrates a needle-less syringe with a needle hub
passing through an aperture in a thermoplastic elastomer.
[0019] FIG. 12 illustrates one method for manufacturing a connector
having a luer port in accordance with embodiments of the
invention.
[0020] FIG. 13 illustrates one embodiment of a connector for a
fluid conduit coupled to fluid conduit in accordance with one
embodiment of the invention.
[0021] Skilled artisans will appreciate that elements in the
figures are illustrated for simplicity and clarity and have not
necessarily been drawn to scale. For example, the dimensions of
some of the elements in the figures may be exaggerated relative to
other elements to help to improve understanding of embodiments of
the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0022] Embodiments of the invention are now described in detail.
Referring to the drawings, like numbers indicate like parts
throughout the views. As used in the description herein and
throughout the claims, the following terms take the meanings
explicitly associated herein, unless the context clearly dictates
otherwise: the meaning of "a," "an," and "the" includes plural
reference, the meaning of "in" includes "in" and "on." Relational
terms such as first and second, top and bottom, and the like may be
used solely to distinguish one entity or action from another entity
or action without necessarily requiring or implying any actual such
relationship or order between such entities or actions. Also,
reference designators shown herein in parenthesis indicate
components shown in a figure other than the one in discussion. For
example, talking about a device (10) while discussing figure A
would refer to an element, 10, shown in figure other than figure
A.
[0023] Embodiments of the present invention provide a connector for
fluid conduit, such as rubber tubing or other flexible conduit. The
connector includes a luer access port, to which a luer connector of
a needle-less syringe may couple. When the luer connector of the
syringe couples to the luer access port, the needle hub of the
syringe is able to pass through an aperture or opening in a
thermoplastic elastomer, thereby allowing one to take a fluid
sample without penetrating the fluid conduit, and without the use
of a hypodermic needle.
[0024] In one embodiment, the connector includes a tubular
connection member having a lumen passing therethrough. The tubular
connection member includes a male conduit connector and a female
receiver, which can be used for coupling the connector to conduit.
The luer access port, which is a singular, insert-molded part in
one embodiment, is disposed along a waist of the tubular connection
member that is positioned between two higher side portions. To aid
in user comfort, in one embodiment, the luer access port rises no
higher from the waist than one of the side portions. To further aid
in user comfort, in one embodiment the waist and side portions form
a smooth contour without sharp edges.
[0025] Embodiments of the present invention facilitate fluid flow
from one conduit inserted into the female receiver and another
coupled about the male conduit connector through a lumen passing
along a longitudinal axis of the tubular connection member. The
luer access port extends from the tubular connection member along a
transverse axis, which may be oriented orthogonally relative to the
longitudinal axis. The thermoplastic elastomer of the luer access
port ensures that fluid passes through the main lumen until either
a slip luer or a lock luer is coupled to the cylindrical body of
the luer access port. As the luer of the syringe connects with the
luer access port, the needle hub passes through the thermoplastic
elastomer, thereby permitting fluid flow along the transverse axis
into the syringe. When the syringe is removed, fluid communication
along the transverse axis stops.
[0026] Embodiments of the present invention offer numerous
advantages over the prior art due to manufacturability. For
example, while prior art luer access ports are often made with many
different parts, in one embodiment of the present invention only
two parts are used, as the luer access port is formed in a single
mold by way of a insert molding process. This manufacturing method
results in a smaller connector having a reduced form factor, as
well as a lower cost connector. Size can be important in fluid
connector design as connectors in accordance with the present
invention are frequently used in procedures involving catheters.
When used with a catheter, the connector can be placed atop the leg
of the patient. If the patient rolls over on the connector, large
connectors can cause irritation. Further, the smooth contours of
various embodiments of the invention include no sharp edges,
thereby also increasing patient comfort.
[0027] Further, embodiments of the present invention provide an
access port with higher reliability when compared to prior art,
multi-piece designs. Higher reliability is due at least in part to
the thermoplastic elastomer being "molded into" the cylindrical
wall. The insert molding process thereby reduces the opportunities
for elastomer failure or the opportunities for fluid to bypass
about a perimeter of the elastomer member, which results in
leakage.
[0028] Other advantages embodiments of the present invention offer
over prior art connectors include the following: First, in the
construction of embodiments of the present invention, only two
materials are needed. A first material is used for the
thermoplastic elastomer, and another material is used for the
cylindrical wall of the luer access port and the tubular connection
member. By contrast, with prior art designs, three or more
different parts are required, each of which can be manufactured
from a different material.
[0029] Next, as the thermoplastic elastomer is insert molded into
the cylindrical housing of the luer access port in one embodiment,
the need for tediously assembling these small parts together is
obviated. This results in faster manufacturing times and reduced
manufacturing cost.
[0030] Third, most prior art access ports consist of a soft valve
material, a rigid housing into which the valve material is glued,
and a third rigid base. With embodiments of the present invention,
the thermoplastic elastomer is permanently bonded into its
cylindrical housing, thereby obviating the need for adhesives or
solvents to contact the thermoplastic elastomer. Additionally,
since the materials are bonded together, there is no need to
provide large amounts of space within the luer access port for
mechanical activation of the syringe valve. This results in a luer
access port having a smaller overall form factor.
[0031] Turning now to FIGS. 1-4, illustrated therein is one
embodiment of a connector for a fluid conduit in accordance with
embodiments of the invention. FIG. 1 illustrates a perspective
view, while FIG. 2 illustrates a side, sectional view. FIG. 3
illustrates a side, elevation view, while FIG. 4 illustrates a top
plan view. The figures will be referred to collectively, with like
reference numerals referring to identical or functionally similar
elements throughout the separate views.
[0032] A tubular connection member 101 has a lumen 200 passing
therethrough. The term "tubular" refers to the fact that a lumen
passes through the connection member along a longitudinal axis.
Note that the term "tubular" does not mean that the tubular
connection member 101 must be cylindrical, although it can be. For
example, in the illustrative embodiment of FIGS. 1-4, various
contours pass long the tubular connection member 101, and result in
ramps, steps, and smooth contours. As such, the tubular connection
member 101 is a connector body that may take any of a variety of
shapes. In one illustrative embodiment, the tubular connection
member 101 has a length 401 of about 3 inches, such as 2.980
inches.
[0033] The lumen 200, which passes along a longitudinal axis of the
tubular connection member 100 facilitates fluid communication
between a male conduit connector 102 and a female conduit receiver
202. As shown in FIG. 2, in one embodiment the female conduit
receiver 202 can be disposed beneath a side portion 109 of the port
supporting region 107. Turning briefly to FIG. 13, the male conduit
connector 102 can be inserted inside a first conduit 1301, which
may be rubber or plastic tubing or other suitable conduit. A second
conduit 1302 then couples within the female conduit receiver 202,
thereby facilitating fluid communication between the first conduit
1301 and the second conduit 1302 through the lumen 200.
[0034] Turning now back to FIGS. 1-4, in one embodiment the male
conduit connector 102 is configured as a ramp 103 extending from a
steeper insertion ramp 104 disposed at a first end 105 of the
tubular connection member 101, distally along the tubular
connection member, to a termination ramp 203. An optional sleeve
106 is disposed behind the termination ramp 203, which extends from
the termination ramp 203 to a walled stop 204. The length 402 of
the combined insertion ramp 104, ramp 103, termination ramp 203,
and sleeve 106, in one embodiment, is about 1.180 inches.
[0035] As shown in FIG. 13, when a first conduit 1301 is slipped
over the male conduit connector 102, the end 1303 of the first
conduit 1301 may slip into the sleeve 106. As such, the termination
ramp 203 serves as a stop to retain the first conduit on the male
conduit connector 102. Further, the walled stop 204 helps to
prevent the first conduit 1301 from sliding too far along the
tubular connection member 101.
[0036] Turning back to FIGS. 1-4, beyond the sleeve 106 is disposed
a port support region 107 comprising a waist 108 disposed between
two side portions 109,110. As shown in the illustrative embodiment
of FIGS. 1-4, in one embodiment each of the two side portions
109,110 is has a height 301,302 that is greater then a waist height
205. For example, a first side portion height 301 may be 0.664
inches, while a second side portion height 302 is 0.692 inches. The
waist height 205 may only be 0.400 inches. The length 403 of the
port support region 107, in one embodiment, is about 1.800 inches.
These values are illustrative only, in that one of ordinary skill
in the art having the benefit of this disclosure will find it
obvious that other dimensions have been used. However, these
dimensions have been shown in experimental testing to work well in
practice.
[0037] As shown in the illustrative embodiment of FIGS. 1-4, the
port support region 107 has a cross sectional shape that is
non-cylindrical. In the illustrative embodiments of FIGS. 1-4, the
port support region 107 has an hourglass or "pinched cigarette
butt" appearance as the port support region 107 tapers from a first
side portion 109 to the waist 108 to the second side portion 110.
Note that in the illustrative embodiments of FIGS. 1-4, the waist
108, first side portion 109, and second side portion 110 have
widths 404,405,406 that are different from their respective heights
301,302,205. For example, while the waist 108 may have a waist
height 205 of 0.400 inches, its width 404 may be 0.498 inches.
Similarly, while the first side portion 109 may have a height of
0.664 inches, its width 405 may be only 0.581 inches. Accordingly,
while the second side portion 110 may have a height of 0.692
inches, its width 406 may only be 0.638 inches. The widths and
heights of the port support region 107 could be the same as
well.
[0038] As noted above, in some applications the connector 100 will
be used in a catheter process in which the connector 100 is placed
along, or very near to, a person's leg or arm. As such, a person
can roll onto the connector 100 at times. To aid in user comfort,
as shown in FIGS. 1-4, in one embodiment the surface area 112
defining the contours flowing along the port support region 107 are
smooth and are devoid of corners or sharp edges.
[0039] Disposed along the waist 108 is a port receiving aperture
111. The port receiving aperture 111 includes its own lumen 206
that is disposed about a transverse axis 207. In one embodiment,
the transverse axis 207 is orthogonal with the longitudinal axis
201, although other angles can be used as well. The port receiving
aperture 111 is configured to couple to the access port that will
be described with respect to the figures below.
[0040] Turning now to FIG. 5, illustrated therein is one embodiment
of a thermoplastic elastomer 500 suitable for use with embodiments
of the invention. While the thermoplastic elastomer 500 is shown as
an independent element in FIG. 5, as will be described below it can
be integrated into a cylindrical wall in an insert molding process.
Where this is the case, the cylindrical wall and thermoplastic
elastomer 500 will be removed from the mold in a single piece. The
illustration of the thermoplastic elastomer 500 shown in FIG. 5 is
used to show some features and characteristics of one exemplary
embodiment.
[0041] As shown in FIG. 5, the thermoplastic elastomer 500 includes
a domed interior portion 501 surrounded by a stair-stepped
perimeter portion 502. In this illustrative embodiment, the
stair-stepped perimeter portion 502 includes two steps, although
those of ordinary skill in the art having the benefit of this
disclosure will understand that other numbers of steps can be used.
The steps serve to provide additional surface area to which the
cylindrical sidewall can adhere.
[0042] Further the lower step 503 of the thermoplastic elastomer
500 may be integrated into the cylindrical sidewall, thereby
leaving the domed interior portion 501 free to move. In one
embodiment, the thermoplastic elastomer 500 is manufactured from a
flexible, resilient material having both thermoplastic and
elastomeric properties. One suitable material shown to work well in
practice is Versaflex.RTM. OM 9-802CL offered by GLS Corporation.
This material is clear and readily combines with polycarbonate
resins in insert molding processes.
[0043] Turning now to FIG. 6, illustrated therein is one embodiment
of a cylindrical wall 600 that is formed about the thermoplastic
elastomer (500) of FIG. 5. As with the thermoplastic elastomer
(500) of FIG. 5, the cylindrical wall is shown as an independent
element in FIG. 6. However, as will be described below, it can be
integrated about the thermoplastic elastomer (500) in an insert
molding process. Where this is the case, the cylindrical wall 600
and thermoplastic elastomer (500) will be removed from the mold in
a single piece. The illustration of the cylindrical wall shown in
FIG. 6 is used to show some features and characteristics of one
exemplary embodiment.
[0044] In one embodiment, the cylindrical wall 600 is configured as
a cylinder such that it will easily slip between a luer connector
and needle hub of a syringe. The cylindrical wall 600 can be
manufactured from a rigid thermoplastic, such as ABS,
polycarbonate, polycarbonate-ABS, and so forth. In one embodiment,
polycarbonate is used for the cylindrical wall 600 due to the fact
that it easily bonds with polyvinyl chloride materials with
commonly available solvents such as cyclohexanone or methylene
chloride.
[0045] The cylindrical wall 600 can be configured to couple with
slip luer connections or locking luer connections. Where the
cylindrical wall 600 is configured to couple to a locking luer
connection, in one embodiment, the cylindrical wall 600 includes
one or more male engagement members 601,602 extending therefrom.
These male engagement members 601,602 are configured to engage the
locking mechanism of a locking luer connector, which may be in the
form of threads, twist snaps, or other mechanical configurations.
Where the cylindrical wall 600 is configured to couple to slip luer
connectors, the male engagement member 601,602 may be omitted.
However, a cylindrical wall 600 having male engagement member
601,602 that only slightly protrude from the perimeter wall 603 so
as to either engage the locking mechanism of a locking luer
connector, or to slide within a slip luer connector.
[0046] In one embodiment, the cylindrical wall 600 includes a
terminating ledge 604 that is complementary in shape to the
stair-stepped perimeter (502) of the thermoplastic elastomer (500).
During the insert molding process, the terminating ledge 604 fuses
with the stair-stepped perimeter (502), thereby forming a unitary
luer access port.
[0047] Turning now to FIG. 7, illustrated therein is one embodiment
of a unitary luer access port 700, shown in a sectional view,
comprising a thermoplastic elastomer 500 and a cylindrical wall
600. The unitary luer access port 700 of FIG. 7 has been formed
with an insert molding process, where the stair-stepped perimeter
502 mates with a complementary stair-stepped feature 701 inside the
terminating ledge 604. In one embodiment, the port height 702 is
less than 0.200 inches.
[0048] Turning now to FIG. 8, illustrated therein is another
embodiment of a luer access port 800 in accordance with embodiments
of the invention. In the embodiment of FIG. 8, the domed interior
portion 501 of the thermoplastic elastomer 500 has been cut so as
to reveal an incision 802 spanning a length of the domed interior
portion 501. Note that the length is not the diameter, but is
rather a portion of the domed interior portion 501. The incision
802 defines an aperture that is configured such that a needle hub
of a needle-less syringe may pass through the aperture so as to
draw fluid samples through the luer access port 800. As
thermoplastic elastomer 500 has elastomeric properties, when the
needle hub is withdrawn, the incision 802 closes, thereby stopping
fluid communication through the luer access port 800.
[0049] In one embodiment, the incision 802 is large enough for the
needle hub to fully pass therethrough. However, in one embodiment
the incision 802 is not large enough to extend across the entire
width of the domed interior portion 501, as this can compromise
reliability of the bond between the thermoplastic elastomer 500
with the cylindrical wall 600.
[0050] In one embodiment, the function of the luer access port 800
is to establish fluid communication from a syringe to the lumen of
a flow channel in a connector body or tubular connection member.
When there is not a needle hub inserted into the luer access port
800, no fluid is allowed through the thermoplastic elastomer 500.
When a needle hub is inserted into the luer access port 800, the
thermoplastic elastomer 500 stretches and displaces, thereby
allowing the needle hub to pass through the incision 802 and
establish fluid communication with internal lumen of the connector
body or tubular connection member. To draw a sample of fluid, the
healthcare provider need only insert the needle hub through the
incision 802, thereby causing the luer connector to pass about the
cylindrical wall 600. The healthcare provider can then aspirate the
syringe and draw a sample of fluid. The thermoplastic elastomer 500
material is chosen so that it is soft enough to allow the needle
hub to pass though without resistance. The thermoplastic elastomer
500 material is also chosen so that it is resilient and can close
quickly upon removal of the needle hub to ensure the prevention of
leaks.
[0051] FIGS. 9 and 10, illustrated therein is one embodiment of a
connector 900 for a fluid conduit in accordance with embodiments of
the invention. The fluid connector 900 of FIGS. 9 and 10 includes a
connector body 901 having a main lumen 902 passing therethrough
along a longitudinal axis 903. The connector body 901, in this
illustrative embodiment, is configured just as was the tubular
connection member (101) of FIGS. 1-4, with a port receiving
aperture 904 to which a luer access port 800 is coupled. In one
embodiment, the luer access port 800 is coupled to the port
receiving aperture 904 at the waist 905 of the connector body 901,
which is disposed between two side sections 907,908. In one
embodiment, the luer access port 800 is coupled to the port
receiving aperture 904 of the connector body 901 with adhesives. In
another embodiment, the luer access port 800 can be threaded into
the port receiving aperture 904. In another embodiment, the luer
access port 800 can be sonically or thermally welded into the port
receiving aperture 904.
[0052] Regardless of the means of connecting, in the illustrative
embodiment of FIGS. 9 and 10, the luer access port 800 extends
distally along a transverse axis 905 from a waist 906 of the
connector body 901 that is disposed between two side sections
907,908. In FIG. 9, the luer access port 800 has a height 909 that
is configured such that the luer access port 800 extends from the
connector body 901 to a height that is less than a side section
height 910 of the highest of the two side sections 907,908. In so
doing, the configuration of the connector 900 aids in user comfort
in that the luer access port 800 is not the highest feature. As
such, the combination of both side sections 907,908 and the luer
access port 800 form a three-element surface that will not
substantially irritate a user if the user rolls over the connector
900.
[0053] In one embodiment, the height 910 of the highest of the two
side portions 907,908 is greater than or equal to a waist height
911 of the waist 906 plus the port height 909. For example, where a
height 910 of the higher side portion 908 is 0.400 inches, the
waist height 911 can be less than 0.200 inches and the port height
909 can be less than 0.200 inches. In another embodiment, the
height may be 0.346 inches, while the waist height 911 is 0.200
inches. In this configuration, the port height 909 will be less
than or equal to 0.146 inches.
[0054] Turning now to FIG. 11, illustrated therein is a needle hub
1100 of a needle-less syringe being inserted into one embodiment of
a luer access port 800 coupled to a tubular connection member 101
in accordance with embodiments of the invention. The syringe of
FIG. 11 is a slip luer syringe, as the luer connector 1102 does not
include any luer locking members. Note that even though the syringe
is a slip luer syringe, the cylindrical wall 600 still includes
male engagement members 601,602. However, each male engagement
member 601,602 extends from the cylindrical wall 600 sufficiently
little as to fit within the luer connector 1102.
[0055] As shown in the sectional view of FIG. 11, the needle hub
1100 passes through the incision (802) of the thermoplastic
elastomer 500. The needle hub 1100 thus enters the lumen 1103 of
the luer access port 800, thereby facilitating withdrawal of fluids
from the main lumen 1104 passing through the tubular connecting
member 101.
[0056] Turning now to FIG. 12, illustrated therein are exemplary
methods 1200 for manufacturing a luer access port and a
corresponding connector for fluid conduit with an insert molding
process in accordance with embodiments of the invention. As shown
in FIG. 2, flow 1201 is one exemplary method of forming a luer
access port, while flow 1202 is another. It will be obvious to
those of ordinary skill in the art having the benefit of this
disclosure that other insert molding process flows for creating a
luer access port can be used.
[0057] Generally, the method includes the following steps: forming
a first portion of the luer access port in a mold by injecting a
first material into a cavity of the mold as shown by steps 1203 and
1206; removing at least one tooling component from the cavity,
thereby creating additional cavity space as shown by steps 1204 and
10207; and forming a second portion of the luer access port by
injecting a second material into the cavity about the stair-stepped
elastomer membrane to form the luer access port as shown at steps
1205 and 1208. Where the stair-stepped elastomer is formed first,
the first material injected into the mold will be elastomer, and
the second material will be a thermoplastic like polycarbonate.
When the luer access port body is formed first, the first material
will be a thermoplastic, while the second material will be an
elastomer.
[0058] In one embodiment, this process can be carried out using a
mold having two sets of cores and cavities, where the cores are the
same, but the cavities are different from each other. As such, the
stair-stepped elastomer and luer access port body can be
constructed at the same time, thereby increasing efficiency of
manufacture. Once the luer access port is formed, regardless of
method, it can then be coupled to a connector at step 1209.
[0059] Flow 1201 describes a process in which the luer access port
body is formed first. At step 1203, the luer access port body is
formed by injecting a first material, such as a thermoplastic like
polycarbonate, into an injection mold cavity. At step 1204, the
mold can opened with the luer access port body still within the
mold, thereby forming new cavities. The mold can then rotated 180
degrees out of phase so that the injection equipment is facing the
additional cavities. At step 1205, a separate injection unit of the
injection equipment can then inject a second material, such as an
elastomer, into the new cavities such that it forms with the luer
access port body. This step 1205 completes the formation of a
unitary, integrated luer access access port.
[0060] At step 1209, a connector body is provided. The connector
body, as described with respect to the embodiments above, includes
a first lumen extending along a longitudinal axis and a second
lumen extending along a transverse axis and intersecting the first
lumen. At step 1210, an incision or slit is formed in the
stair-stepped elastomer membrane so as to facilitate passage of a
needle hub therethrough. At step 1210, the unitary, integrated
access port is coupled to the connector body about the transverse
axis as described above. The resulting connector can then be used
or shipped to healthcare providers for use.
[0061] Turning now to flow 1202, in this flow the stair-stepped
elastomer is formed first. Specifically, at step 1206, a
stair-stepped elastomer membrane is formed in a mold by injecting
elastomer material into a first cavity of the mold. The first
cavity, which is for the stair-stepped elastomer membrane, is
blocked from a second cavity for the body cores within the
mold.
[0062] At step 1207, at least one tooling component, such as a
core, is removed from the mold, thereby increasing a cavity size of
the mold and providing exposure of the now formed stair-stepped
elastomer membrane to the second cavity for the body. At step 1208,
a body of a luer access port is formed by injecting thermoplastic
material into the second cavity that has been exposed about the
stair-stepped elastomer membrane. This step 1208 completes the
formation of a unitary, integrated luer access access port. The
luer access port can then be formed into a connector at steps 1209,
1210, and 1211, as described above.
[0063] In the foregoing specification, specific embodiments of the
present invention have been described. However, one of ordinary
skill in the art appreciates that various modifications and changes
can be made without departing from the scope of the present
invention as set forth in the claims below. Thus, while preferred
embodiments of the invention have been illustrated and described,
it is clear that the invention is not so limited. Numerous
modifications, changes, variations, substitutions, and equivalents
will occur to those skilled in the art without departing from the
spirit and scope of the present invention as defined by the
following claims. Accordingly, the specification and figures are to
be regarded in an illustrative rather than a restrictive sense, and
all such modifications are intended to be included within the scope
of present invention. The benefits, advantages, solutions to
problems, and any element(s) that may cause any benefit, advantage,
or solution to occur or become more pronounced are not to be
construed as a critical, required, or essential features or
elements of any or all the claims. The invention is defined solely
by the appended claims including any amendments made during the
pendency of this application and all equivalents of those claims as
issued.
* * * * *