U.S. patent application number 11/417446 was filed with the patent office on 2006-09-21 for soft-grip medical connector.
Invention is credited to Thomas F. Fangrow.
Application Number | 20060211997 11/417446 |
Document ID | / |
Family ID | 36155599 |
Filed Date | 2006-09-21 |
United States Patent
Application |
20060211997 |
Kind Code |
A1 |
Fangrow; Thomas F. |
September 21, 2006 |
Soft-grip medical connector
Abstract
A soft grip medical connector comprises a housing with an
upstream end, a downstream end and a lumen extending through a
central portion thereof. A flexible member comprises a valve
portion integrally formed with a sleeve portion. The valve portion
is positioned within a section of the housing and is configured to
control a flow of fluid through the housing lumen. The sleeve is
inverted to envelope at least a portion of the outer surface of the
housing. In some embodiments the gripping portion is integrally
formed with the valve portion. In some embodiments, the connector
is also generally configured to create a positive pressure in a
catheter lumen upon removal of a syringe or other medical device
from the upstream end of the connector. Methods of making a medical
fluid connector generally comprise forming a valve member with a
sleeve extending there from, and assembling the valve, sleeve and
housing.
Inventors: |
Fangrow; Thomas F.; (Mission
Viejo, CA) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE
CA
92614
US
|
Family ID: |
36155599 |
Appl. No.: |
11/417446 |
Filed: |
May 3, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11267822 |
Nov 4, 2005 |
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11417446 |
May 3, 2006 |
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60625644 |
Nov 5, 2004 |
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60654250 |
Feb 18, 2005 |
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Current U.S.
Class: |
604/246 |
Current CPC
Class: |
A61M 39/22 20130101;
A61M 39/045 20130101; A61M 2039/263 20130101; A61M 39/26 20130101;
Y10T 29/49826 20150115; A61M 2039/266 20130101; A61M 2205/02
20130101; A61M 2205/586 20130101; A61M 39/10 20130101 |
Class at
Publication: |
604/246 |
International
Class: |
A61M 5/00 20060101
A61M005/00 |
Claims
1. A medical valve comprising: a housing, the housing having an
upstream end, a downstream end, an outer surface, and a lumen
extending through a central portion thereof; and a flexible member,
the flexible member comprising: a valve portion, at least a
substantial portion of the valve portion being positioned within
the housing, the valve portion configured to receive a medical
device and to control a flow of fluid through the housing lumen;
and a gripping portion, the gripping portion disposed over at least
a portion of the outer surface of the housing, and the gripping
portion unitarily formed with the valve portion; wherein the
housing comprises at least one ring section extending radially
outwards from the outer surface of the housing and wherein the
gripping portion includes at least one protrusion engaged with the
ring section to retain the gripping portion on the housing.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 11/267,822, filed Nov. 4, 2005, pending, which
claims the benefit of U.S. Provisional Application No. 60/625,644,
filed on Nov. 5, 2004, and U.S. Provisional Application No.
60/654,250, filed on Feb. 18, 2005, the entireties of which are
hereby incorporated by reference.
BACKGROUND OF THE INVENTIONS
[0002] 1. Field of the Invention
[0003] The inventions disclosed herein relate in general to the
field of medical connectors, and in particular to needle-less
medical connectors.
[0004] 2. Description of the Related Art
[0005] The manipulation of fluids for parenteral administration in
hospitals and medical settings routinely involves the use of
connectors for selectively facilitating the movement of fluids to
or from patients. For example, a connector may be attached to a
catheter that leads to a tip positioned within a patient, and
various connectors may be attached to one or more tubes and medical
implements to control the fluid flow to or from the patient.
[0006] Needle-less connectors are typically structured so that a
medical implement without a needle can be selectively connected to
such a connector for providing fluid flow between a patient and a
fluid source or receptacle. When the medical implement is removed,
the connector closes, effectively sealing the catheter connected to
the patient without requiring multiple injections to the patient
and without exposing health care professionals to the risk of
inadvertent needle sticks. The medical implement used with the
connector may be a tube or other medical device such as a conduit,
syringe, IV set (both peripheral and central lines), piggyback
line, or similar component which is adapted for connection to the
medical valve.
[0007] Many existing medical connectors can be relatively difficult
to grasp by health care professionals during use. In most
applications, medical connectors are designed to be relatively
small to minimize the cost of manufacturing and to minimize the
amount of fluid "dead space" inside the connectors. Moreover, most
medical connectors include a housing with a hard, smooth outer
surface. As a result, it is sometimes uncomfortable for health care
professionals to tightly pinch their fingers around the connectors
and firmly grasp them during medical procedures in a repetitious
manner. Because health care professionals use such connectors very
frequently during patient care, enhancements in their ability to
effectively grasp the connectors can result in significant
improvement in the time and effort required to use them.
Additionally, the existing hard-surface medical connectors can be
uncomfortable against a patient's skin. This discomfort can become
especially pronounced when a patient requires frequent medical
attention involving the use of medical connectors, such as
hemodialysis.
[0008] Additionally, many existing medical connectors at least
partially obstruct fluid flow with complex flow passageways
including various turns, bends, and corners. These obstructions can
result in a fairly low flow rate. The obstructions can also damage
blood platelets.
[0009] Further, many existing connectors permit some degree of
retrograde fluid flow upon the disconnection of these medical
devices from the valve. These connectors typically include an
internal space through which a fluid may flow from the medical
implement to the catheter attached to the connector. When the
medical implement is attached to the connector, it typically
occupies a portion of this internal valve space, displacing a
certain amount of fluid within the connector. When the medical
implement is disconnected, a vacuum is created by the removal of
the portion of the medical implement from the internal space of the
connector, which tends to draw fluid up through the line from the
patient toward the connector to fill the space left by the removal
of the implement.
[0010] This regression of fluid has certain disadvantages. When the
connector is attached to a fluid line leading to a patient,
retrograde movement of fluid through the line towards the space in
the connector has the effect of drawing a small amount of blood
away from the patient in the direction of the connector. The blood
thus drawn into the catheter may, over time, result in a clog in
the catheter near its tip, potentially limiting the effectiveness
of the catheter tip.
[0011] The likelihood of blood clogging the tip of a catheter is
heightened when the inner diameter of the catheter is small. In
parenteral applications, such smaller-diameter catheters are used
frequently due to their numerous advantages. For example, smaller
catheters reduce the trauma and discomfort caused by insertion into
a patient. Because these catheters have small lumens, even a small
suction force may draw fluid back a comparatively large distance
through the catheter toward the connector.
[0012] Further, in some existing medical connectors, there are gaps
between an internal sealing member and the outer housing of the
connector. These gaps may allow bacteria, debris, or disinfectant
solution to enter through the opening into the interior of the
connector and potentially reach the flow of fluid to or from the
patient.
SUMMARY OF THE INVENTIONS
[0013] Certain embodiments of the present invention provide a
soft-grip medical connector comprising a housing with an upstream
end, a downstream end, a lumen extending through a central portion
of the housing, and a flexible member. In some embodiments, the
flexible member has a valve portion integrally formed with a
gripping portion. The valve portion is positioned within a portion
of the housing. The valve portion is configured to control a flow
of fluid through the housing lumen. The gripping portion covers at
least a portion of an outer surface of the housing.
[0014] In some embodiments, a medical fluid connector comprises a
cylindrical body, a valve portion, and a sleeve portion. The
cylindrical body has an outer wall with a plurality of flanges
extending radially therefrom and a lumen extending through a
portion thereof. The valve portion provides a closeable seal
between a first end and a second end of the cylindrical body. The
sleeve portion can be unitarily formed with the valve portion and
can surround a substantial portion of an outer surface of the
cylindrical body.
[0015] Methods of forming a gripping and/or sealing portion of a
medical device are also provided. In some embodiments, a method
comprises injecting an uncured material into a mold, thereby
molding a first preform from a substantially flexible material. The
preform is removed from the preform mold, and a second preform is
molded (though not necessarily in the same mold as the first). The
first preform and the second preform are then inserted into a final
mold, and an uncured material is injected into the final mold in
order to over-mold the first and second pre-forms into a final
structure having a valve member and a sleeve portion extending from
the valve member.
[0016] Methods of making a medical fluid connector are also
provided. In some embodiments, the methods comprise the steps of
forming a valve member with a sleeve extending therefrom, the valve
and sleeve being integrally formed of a substantially flexible
material and forming a relatively rigid housing. A portion of the
valve member is inserted into a cavity of the housing such that the
sleeve extends from the housing member. The sleeve is then inverted
to cover or surround at least a portion of an outer surface of the
housing member.
[0017] In embodiments of a method of using a soft-grip connector,
the downstream end is connected to a first medical implement such
as a catheter. A second medical implement is inserted into an
opening in the upstream end of the connector. Upon introduction of
the second medical implement into the connector, in certain
embodiments, the valve member expands, creating a larger internal
volume. Fluid from the second medical implement is permitted to
flow into the valve member. In some embodiments, this introduction
of fluid causes further expansion of the volume inside the valve
member, and as the fluid flow diminishes or stops, the inside
volume of the valve member contracts.
[0018] As the second medical implement is withdrawn from the
connector, the internal volume of the valve member also decreases.
In some embodiments, the valve member can rapidly return to its
original state (i.e., before insertion of the second medical
implement). A region inside of the valve member near the upstream
end is narrower than a region near the downstream end to impede the
flow of fluid in the upstream direction and encourage the flow of
fluid in the downstream direction. In this way, fluid inside the
connector is forced toward the downstream end of the connector in
the direction of the patient, creating a positive flow effect and
minimizing regression of fluid back into the valve. Various
configurations of positive-flow valves are disclosed in U.S. Pat.
No. 6,695,817 and U.S. Patent Application Publication No.
2004/0006330, owned by ICU Medical, Inc., and such documents are
incorporated herein by reference and form a part of this
specification for all that they disclose.
[0019] In many embodiments, the connector is small yet easily
grippable. The outer sleeve can be made, for example, of silicone
rubber, which creates a desirable degree of anti-slip friction
against standard rubber gloves worn by health care professionals.
In some embodiments, the contours of the connector in the region
near the upstream end are generally smooth and seamless due to the
integral formation of the flexible outer sleeve and the valve
member. In this configuration, it is less likely that bacteria or
other debris will gather in areas where fluid flow passes through
to the patient and it is easier and more effective to swab such
areas with antiseptic. The integral formation of the valve member
and outer sleeve also simplifies, and increases the
cost-effectiveness, of the manufacturing processes.
BRIEF DESCRIPTION OF DRAWINGS
[0020] Having thus summarized the general nature of the invention,
certain preferred embodiments and modifications thereof will become
apparent to those skilled in the art from the detailed description
herein having reference to the figures that follow, of which:
[0021] FIG. 1 is a perspective view of one embodiment of a
soft-grip medical connector including an outer sleeve surrounding a
housing member;
[0022] FIG. 2 is a perspective view of one embodiment of a housing
member of a soft-grip medical connector;
[0023] FIG. 3 is a top plan view of the housing member of FIG.
2;
[0024] FIG. 4 is a bottom plan view of the housing member of FIG.
2
[0025] FIG. 5 is a transverse cross-sectional view of the housing
member of FIG. 2 taken through line 5-5 (shown in FIG. 3);
[0026] FIG. 6 is a transverse cross-sectional view of the housing
member of FIG. 2 taken through line 6-6 (shown in FIG. 3);
[0027] FIG. 7 is an exploded perspective view of another embodiment
of housing member of a soft-grip medical connector;
[0028] FIG. 8A is a perspective view of a first housing portion of
the housing member of the housing member of FIG. 7;
[0029] FIG. 8B is a perspective view of the first housing portion
of FIG. 8A from a reverse angle;
[0030] FIG. 9A is a perspective view of a second housing portion of
FIG. 7;
[0031] FIG. 9B is a perspective view of the second housing portion
of FIG. 9A from a reverse angle;
[0032] FIG. 10 is a transverse cross-sectional view of the housing
member of FIG. 7 taken through line 10-10;
[0033] FIG. 11 is a transverse cross-sectional view of the housing
member of FIG. 7 taken through line 11-11;
[0034] FIG. 12 is a perspective view of a flexible member including
a valve member and a sleeve connected to the valve member;
[0035] FIG. 13 is a cross-sectional view of the connector of FIG.
12, taken through line 13-13;
[0036] FIG. 14 is a cross-sectional view of the flexible member of
FIG. 12, taken through line 14-14;
[0037] FIG. 15 is a perspective view of one embodiment of a preform
for use in manufacturing some embodiments of a flexible member;
[0038] FIG. 16 is a perspective view of another embodiment of a
flexible member including a valve member and a sleeve connected to
the valve member;
[0039] FIG. 17 is a cross-sectional view of the flexible member of
FIG. 16, taken through line 17-17;
[0040] FIG. 18 is a cross-sectional view of the flexible member of
FIG. 16, taken through line 18-18;
[0041] FIG. 19 is a perspective view of a third embodiment of a
flexible member having a member and a sleeve connected to the valve
member;
[0042] FIG. 20 is a cross-sectional view of the flexible member of
FIG. 19, taken through line 20-20;
[0043] FIG. 21 is a cross-sectional view of the flexible member of
FIG. 19, taken through line 21-21;
[0044] FIG. 22 is a perspective view illustrating an assembly of a
flexible member with a housing member;
[0045] FIG. 23 is a perspective view illustrating the sleeve of the
flexible member housing member, with the valve member of the
flexible member inserted into the housing member.
[0046] FIG. 24 is a cross-sectional view of an assembled soft-grip
medical connector;
[0047] FIG. 25 is a cross-sectional view of a soft-grip medical
connector taken at about 90.degree. relative to the cross-section
of FIG. 24.
[0048] FIG. 26 is a cross-sectional view of the connector of FIG.
24 with a syringe connected thereto; and
[0049] FIG. 27 is a cross-sectional view of the connector of FIG.
24 taken at about 90.degree. relative to the cross-section of FIG.
26.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0050] With reference to the attached figures, certain embodiments
and examples of soft-grip medical connectors will now be described.
Although certain embodiments and examples of a soft-grip connector
are shown and described as including positive-flow valves, certain
aspects and advantages of the systems and methods described herein
can be advantageously applied to numerous other fluid connector
designs including those without positive-flow characteristics.
[0051] Referring now to FIG. 1, the illustrated embodiment of a
medical connector 10 comprises a substantially rigid housing 12
with a flexible member 80 that has been stretched over the outer
surface of the housing 12 to provide a soft, grippable outer
surface 22. A slit opening 100 is formed at an upstream end 16 of
the flexible member 80. The upstream end of the flexible member 80
surrounding the housing 12 provides a surface that is easily
cleaned, and is substantially free from cavities or recesses in
which contaminants may collect. While as illustrated, the upstream
end of the flexible member 80 surround the entire circumference of
the housing 12, it is contemplated that in other embodiments, the
upstream end of the flexible member may circumferentially surround
substantially all of the housing 12, or can circumferentially
surround a portion of the housing 12 such as approximately
three-quarters, approximately one-half, or less. In other
embodiments, the flexible member 80 can be segmented to surround
multiple portions of the housing 12. For example, the flexible
member 80 can have one or more openings or perforations that expose
a portion of the underlying housing 12 beneath the flexible member
80, and/or the portions of the flexible member 80 on the outside of
the housing 12 can be made of strips or bands that contact the
housing 12. The outer surface of the flexible member 80 can cover
internal portions of the flexible member 80, such as lateral
extensions 84 (discussed in further detail below), to prevent
interference with those portions during use, thereby providing for
more consistent functionality of the flexible member 80.
[0052] Referring now to FIGS. 2-11, embodiments of a housing 12 are
described. FIGS. 2-6 depict one embodiment of a housing 12 for use
in a soft-grip medical connector. FIGS. 7-11 depict another
embodiment of a housing for use in a soft-grip medical connector.
Many other embodiments can also be formed by using or combining one
or more features of the disclosed embodiments.
[0053] With reference to the housing depicted in FIGS. 2-6, the
housing 12 comprises an upper cavity 42 for receiving a flexible
member 80, and interfaces 16, 30 for joining the connector to a
variety of medical devices. An upper housing 40 generally comprises
a cylindrical wall 44 having longitudinal slots 46 positioned on
opposite sides, e.g., oriented at about 180.degree. relative to one
another. At a lower end, the upper housing 40 joins a base member
48 which comprises a lower Luer connector 30 (see, e.g., FIGS. 5
and 6). During storage and shipping of a sterilized connector 10, a
protective cap (not shown) can be attached to the lower Luer
connector 30 to maintain its sterility before use. The cap is
generally removed by a health care professional immediately before
connecting the lower Luer connector 30 to a medical implement.
[0054] As illustrated, embodiments of a housing member 12 can also
include a plurality of ring sections 60 extending radially outwards
from the outer surface of the cylindrical wall 44 of the upper
housing 40. In some embodiments, the rings 60 are progressively
smaller in diameter from top 60a to bottom 60c. In still other
embodiments, the number, size, and configuration of the rings 60
can be modified in many other ways.
[0055] Flanges 62 can also be provided at the intersections between
the rings 60 and the slots 46. The flanges 62 prevent lateral
extensions 84 of the flexible member 80 (see, e.g., FIG. 23), when
inserted into the upper housing 40, from snagging or catching on
the edges of the rings 60 at the points where such rings 60 are
bisected by the longitudinal slots 46. The rings 60 and flanges 62
are generally configured to retain portions of a sleeve 20 on the
flexible member 80, as will be discussed in further detail
below.
[0056] As illustrated in FIGS. 1, 5 and 6, the progressively
smaller diameter rings 60 coupled with a frustoconically shaped
skirt 52 generally result in an "hourglass" shaped housing. This
advantageously assists in providing an easily grippable connector.
The smaller-diameter region near the lower end of the upper housing
40 can be grasped between the thumb and index finger of a health
care professional. In the region of the rings 60, the progressively
larger diameter regions above and below the smaller-diameter region
make it less likely that the person's grip will slide along the
outside surface of the connector 10 when other medical implements
are attached to it or detached from it. In addition, other gripping
surfaces such as bumps, ridges, and other types of indentations or
protrusions can be provided on the outside surface of the sleeve 20
in the region where the health care provider's fingers are expected
to grasp the connector 10.
[0057] The dimensions of the housing 12 preferably allow for a
compact connector. Advantageously, a compact connector is
relatively low cost as it requires a relatively small amount of
material to manufacture. Further, the compactness typically results
in a lightweight connector, thus reducing irritation to a patient
when a connector is rested on or hanging from the patient for a
relatively long duration use. For example, in some embodiments, the
housing 12 has a height from an upstream end 16 to a downstream end
of a Luer cannula 32 of between about 0.400'' and 1.200''. In other
embodiments, the height of the housing 12 can be between about
0.500'' and 1.000''. In still other embodiments, the height is less
than 1.000''. The height of the upper housing 40 from an upstream
end 16 to the lower Luer connector 30 is between about 0.500'' and
0.750''. Preferably, the upper housing 40 comprises approximately
three-fourths to four-fifths of the overall height of the housing
12. A Luer cavity 74 has a height extending from the lower end 36
of the housing 12 to a lower surface of the base member 48. In
certain embodiments, the height of the Luer cavity is between
approximately 0.150'' and 0.350''. In other embodiments, the height
of the Luer cavity is less than approximately 0.400''. In a certain
embodiment, the height of the Luer cavity is approximately 0.220''.
Preferably, the height of the Luer cavity 74 corresponds to a
length of a Luer connector to be inserted in the Luer cavity 74
such that the Luer connector can be flushly inserted into the Luer
cavity 74. Preferably, the height of the Luer cavity 74 comprises
from between approximately one-eighth to approximately one-third of
the height of the housing 12. In certain embodiments, a Luer
cannula 32 extends past the lower end 36 of the housing 12
approximately 0.050'' to 0.150''. In other embodiments, the Luer
cannula 32 extends past the lower end 36 approximately 0.80'' to
0.120''. In a certain embodiment, the Luer cannula 32 extends past
the lower end 36 approximately 0.093''. Preferably, the Luer
cannula is sized and configured to couple with a Luer connector to
be inserted into the Luer cavity 74
[0058] The dimensions of the rings 60 and other housing structures
correspond to features of the sleeve 20 as will be further
described below. For example, in some embodiments, the cylindrical
wall 44 has an outer diameter of between about 0.200'' and about
0.300'', preferably between about 0.250 and about 0.275, and in one
particular embodiment, a diameter of about 0.265. In such
embodiments, the upper ring 60a has a height `h` (i.e. the
difference between the outer diameter of the ring and the outer
diameter of the cylindrical upper housing) of about 0.110''
(.+-.0.02''), the middle ring 60b has a height of about 0.093''
(.+-.0.02''), and the lower ring 60c has a height of about 0.073''
(.+-.0.02''). Thus, in certain embodiments, the housing 12 includes
a generally hourglass-shaped body defined by the cylindrical wall
44 and the rings 60a, 60b, 60c and having a maximum diameter of
between about 0.310'' and 0.410'', preferably between about 0.360''
and 0.385'', and in one particular embodiment, about 0.375''. Other
dimensions within and outside of the above ranges can also be used
depending on the particular application desired.
[0059] As shown, for example, in FIGS. 1, 2 and 5, the housing 12
can also include protrusions 70 such as lugs for receiving a
threaded medical connector such as a Luer connector of a medical
device such as a syringe. In the illustrated embodiment, the
protrusions 70 lugs are generally rectangular in shape. The lugs
can also have substantially rounded or beveled edges so as to
prevent damage to the sleeve 20 of the flexible member 80 after it
is stretched over the outside of the housing 12, as described in
greater detail below. The sleeve 20 can include windows 126
configured to allow the protrusions 70 to protrude through the
flexible member 80, while preferably tightly engaging the periphery
of the protrusions 70, when the sleeve 12 is inverted (as will be
discussed in further detail below). In other embodiments, the
protrusions 70 can comprise other shapes and configurations as
desired. In some embodiments without windows 126, the protrusions
70 are sized to cooperate with a thickness of the sleeve, such that
the protrusions 70 form a lump in the sleeve sufficient to engage a
female thread of a Luer connector to be attached to the upstream
end 16 of the connector 10.
[0060] In some embodiments, the lower housing interface comprises a
Luer connector 30 to facilitate joining the connector 10 to medical
devices with female Luer connectors. The Luer connector 30 of the
housing 12 can comprise a hard cannula 32 extending downwardly from
the lower end 36 of the housing 12 to provide a connection with
another medical device, such as a catheter hub. Other interfaces
and connections can also be used in place of the Luer connector 30,
such as Luer slip connections, barbed hose fittings, etc.
[0061] As shown in FIGS. 5 and 6, the housing also includes an
interior cannula 50 extending into the upper housing cavity 42. The
interior cannula 50 comprises a lumen 45 extending through the base
member 48 and through the Luer cannula 32 of the lower Luer
connector 30. The lower Luer connector 30 also includes a skirt 52
which extends downwards from the base member 48 and typically
comprises internal threads 56 or other features for securing the
connector 10 to another medical device. The skirt 52 can comprise a
taper from a narrower upper portion to a larger-diameter lower
portion. In some embodiments, the skirt 52 also includes an incut
annular groove 54 around the perimeter of the skirt 52 at a lower
portion thereof. This annular groove 54 can be used to retain a
portion of the sleeve as will be described in further detail
below.
[0062] In certain embodiments, it is desirable to provide vents 72
(see FIG. 4) between the upper housing cavity 40 and the cavity 74
defined by the lower Luer skirt 52. Since the outer surfaces of the
housing 12 are generally in contact with the sleeve 20 in the final
assembly (and, as discussed below in connection with assembly of
the medical connector 10, in certain embodiments, the sleeve 20 can
cover the entire outer surface, or nearly the entire outer surface,
of the housing 12), such ventilation between the upper housing 40
and the cavity 74 is helpful in allowing air, gaseous sterilizing
agents or other gases to flow freely into and/or out of the upper
housing cavity. This ventilation can be particularly helpful when
and as a medical implement is inserted into the slit opening 100 of
the connector 10 and the flexible member 80 expands, diminishing
the volume between the outer surface of the flexible member 80 and
the inner wall of the upper housing 40. The vents 72 may also allow
moisture and other liquids to flow freely into and/or out of the
upper housing cavity, thus reducing the risk that a volume of
liquid could become trapped in the upper housing 40 and restrict
expansion of the flexible member 80, provide a hospitable
environment for the growth of unwanted bacteria, or otherwise
adversely affect the operation of the medical connector 10. Without
venting, such insertion of the medical implement could be met with
resistance, creating undue wear on the flexible member 80 and
requiring additional effort to use the connector 10. Similarly,
recessed vents 76 can be provided in the lower end 36 of the Luer
skirt 52 to allow air or other gases to escape from the interior of
the Luer cavity 74 while the connector 10 is attached to another
medical device. Additionally, the recessed vents 76 allow air or
other ambient gases to enter the Luer cavity 74 while the other
medical device is removed from the medical connector 10 such that
the medical device does not become vacuum locked to the medical
connector 10. The recessed vents 76 also allow water, cleaning or
disinfecting solutions, or other liquids to escape the Luer cavity
74 while the medical connector 10 is connected to another medical
device. In some embodiments, it can be desirable to provide
ventilation holes in the sleeve 20 itself.
[0063] With reference to FIGS. 7-11, in certain embodiments, the
soft-grip medical connector comprises a housing formed of more than
one housing portion. In the illustrated embodiments, the housing is
formed of a first housing portion 41 and a second housing portion
51. FIG. 7 illustrates an exploded perspective view of a two-piece
housing. FIGS. 8A and 8B are perspective views of the first housing
portion 41, and FIGS. 9A and 9B are perspective views of the second
housing portion 51.
[0064] In some embodiments, a two-piece housing may include many or
all of the structural features of the housing illustrated in FIGS.
2-6 and described above. In other embodiments, the housing may
include more than two pieces. The two-piece housing illustrated in
FIGS. 7-11 includes protruding lugs 71 for receiving a threaded
medical connector such as a Luer connector of a medical device such
as a syringe. The first housing portion 41 also includes
longitudinal slots 49 oriented at approximately 180.degree.
relative to each other. In some embodiments, a different number of
slots or ridges can be provided and the slots or ridges can be of
sizes or positions. The first housing portion 41 defines an upper
cavity 43 for receiving a flexible member 80. The second housing
portion 51 includes a threaded Luer cavity 59. Additionally, the
second housing portion may include recessed vents 77 in the lower
surface of the Luer cavity 59. The second housing portion includes
an interior cannula 53 comprising a lumen 55 extending through the
second housing portion 51. Moreover, the second housing portion may
include vents 57 between the first housing portion 41 and the
second housing portion 51. Further, it is contemplated that a
two-piece housing can have dimensions corresponding to the ranges
discussed above with respect to the embodiments of one-piece
housing 12 illustrated in FIGS. 2-6. Therefore, in certain
embodiments of medical connector, a two-piece housing could be used
interchangeably with a one-piece housing
[0065] The two piece housing illustrated in FIGS. 7-11 also can
also include additional features. For example, the two-piece
housing can include various alignment and coupling features to ease
assembly of the first housing portion 41 with the second housing
portion 51 into a complete housing. For alignment, the second
housing portion may include at least one ridge 65, and the first
housing portion at least one corresponding recess 63. As
illustrated in FIG. 7, the ridge 65 and sidewall 63 are configured
to align the first housing portion 41 in a desired orientation with
the second housing portion 51 during assembly of the housing. To
retain the housing in a coupled orientation, the first housing
portion 41 includes at least one tab 89, and the second housing
portion 51 includes at least one recess 85 configured to receive
the tab 89. As illustrated, the tab 89 has a wedge-shaped profile
including a lead-in surface and an interference surface such that
the lead in surface facilitates insertion of the tab 89 into the
recess and the interference surface prevents withdrawal of the tab
89 from the recess 85. While described herein and illustrated in
terms of certain structures, it is contemplated that other
alignment and coupling features can be used to couple the two
housing portions 41, 51.
[0066] In the housing illustrated in FIGS. 7-11, the assembly of
first and second housing portions 41, 51 results in a space 61
between the housing portions 41, 51. Advantageously, the space 61
may be sized and configured to retain an end of a flexible member
81. Thus, in such a configuration, the rings 60 used in one-piece
housing 12 (FIGS. 2-6) need not be present on a two-piece housing
to reduce slippage of the housing relative to a flexible member 80
disposed thereon. In order to further reduce slippage of a flexible
member 80 relative to the housing, an area of the first housing
portion adjacent the lugs 71 may include a recess 73 to receive an
adhesive such that the flexible member 80 may be adhered to the
housing. The adhesive and housing materials should be chosen to be
compatible. For example, a silicone-based adhesive may be applied
to adhere a glass-reinforced thermoplastic polyester resin housing
to a silicone rubber sleeve 20. In addition to the slippage
reduction noted above, the two-piece housing depicted in FIGS. 7-11
may be manufactured quickly and inexpensively in two separate
one-step molding processes as opposed to a two-step molding process
required to manufacture a more complex single-piece housing.
[0067] As illustrated in FIGS. 12-14, in some embodiments, the
valve member 14 and sleeve 20 are unitarily formed in a flexible
member 80. The flexible member 80 is shown removed from the housing
12 to emphasize details. Some embodiments of valve member 14 have a
seal body 82 which may take the form of a slab-like structure that
is relatively thin in one dimension and relatively wide in another.
The valve member 14 is configured to selectively seal the
connector. The term "seal" is used herein for convenience to refer
to structures capable of impeding fluid flow but does not
necessarily denote that such structures, either alone or in
combination with other structures, form a barrier that is
completely impermeable to fluid flow. In some embodiments, the body
82 comprises lateral extensions 84 extending laterally from the
body 82. The body 82 can also comprise a flat, generally
rectangular neck 86 and a transverse flange 90. In some
embodiments, the sleeve 20 is integrally formed with the flange 90
and extends axially away from the seal body 82.
[0068] The neck 86 is positioned between first and second lateral
extensions 84, which each have shoulders 92 comprising those
portions of the lateral extensions nearest the flange 90. The body
82, neck 86, flange 90, and sleeve 20 can thus form an integral
unit. The body 82 is generally configured to include a narrow
passageway or slit 94 extending through the body 82. The slit 94
generally extends through the body 82 including the neck 86 and the
flange 90. In FIG. 14, the vertical cross-sectional plane of the
drawings coincides with the vertical plane of the slit 94,
revealing the wide horizontal width of the slit 94 on the
downstream end in this dimension. The slit 94 also includes
tapering sides 95, and a narrower neck 97. FIG. 13 demonstrates the
narrowness of the slit 94 in a cross-sectional plan orthogonal to
the cross-sectional plane of FIG. 14.
[0069] As will be described more fully below, the valve member 14
is inserted into the cavity 42 of the housing 12. The slit 94 is
generally sized and shaped to permit insertion of a cannula of a
syringe or other medical device therein. The connector can be
adapted to receive an ANSI standard syringe Luer tip. In some
embodiments, the slit 94 is configured to assist in producing a
valve that exhibits positive flow characteristics.
[0070] The slit 94 extends from the slit opening 100 in the flange
90 to a lead lumen 102 formed in a the downstream end of the body
82 opposite the flange 90. In some embodiments, the lead lumen 102
can be substantially cylindrical and centered about an axis that is
substantially parallel to or collinear with the longitudinal axis
of the valve member 14. The lead lumen 102 can also be provided
with an enlarged external diameter section 104 (e.g. see FIG. 14)
configured to aid in positioning the lead lumen 102 over the
interior cannula 50 of the housing 12 and to avoid unduly
diminishing the cross-sectional area for fluid flow after the
flexible member 80 is so positioned.
[0071] As illustrated in FIG. 13, some embodiments of the slit 94
can be substantially planar and have a very small thickness in the
undisturbed state (i.e. when a syringe cannula is not inserted into
the valve member 14). The slit 94 thus forms a selectively
restricted fluid flow path from the slit opening 100 to the lead
lumen 102. Preferably, the flow path permits either no fluid, or a
clinically negligible amount of fluid, to pass through the flexible
member 80 under the various standard fluid pressure conditions of
patient treatment.
[0072] The slit 94 is generally configured to provide a sealable
fluid pathway between the slit opening 100 and the lead lumen 102.
In some embodiments, the slit 94 can be configured as shown and
described herein or as shown and described in any of the patents
and applications incorporated herein by reference. The slit 94 is
typically made to have essentially no space between adjacent faces
of the slit. Examples of methods for making a suitable seal are
described in further detail below.
[0073] In the embodiment illustrated in FIG. 12, the lateral
extensions 84 generally comprise polygonal, angular shapes,
although other suitable shapes can be used in view of particular
design objectives. The lateral extensions 84 are generally
configured to provide structures that interact with portions of the
housing 12 in order to retain the valve member 14 in the housing 12
at a desired orientation. As illustrated in FIG. 12, dimples 110
can be formed in the flat surfaces of the lateral extensions 84. In
other embodiments, dimples 110 can be formed on another surface of
the valve member 14, and, in still other embodiments, the valve
member 14 does not include dimples 110. The dimples 110 can be used
for retaining and positioning the valve member 14 and lateral
extensions 84 during molding and assembly of the connector as will
be further described below.
[0074] In the embodiments of FIGS. 13 and 14, a sleeve 20 extends
axially from the transverse flange 90 of the valve member 14 to the
opposite end of the flexible element 80. The sleeve 20 can comprise
a first section 112 with a first diameter D1 substantially
corresponding to the diameter of the transverse flange 90, and a
second section 114 with a second diameter D2 that is slightly
larger. In some embodiments, the length of the first section 112
having the first diameter D1 is approximately equal to a distance
between the upstream end 16 of the housing 12, and the upper ring
60a of the housing 12. The second section 114 of the sleeve 20 is
typically sized to be approximately the same diameter as, or
slightly smaller than, the narrowest portion of the
hourglass-shaped housing. Thus, when the sleeve 20 is inverted and
stretched to surround the housing 12, the sleeve 20 will preferably
cling tightly to the exterior surface of the housing along
substantially the entire length of the housing 12.
[0075] To retain the sleeve 20 in an inverted position surrounding
the housing 12, the sleeve 20 can be provided with retaining
structures to engage portions of the housing 12. Such retaining
structures can include any of a variety of structures, such as
protrusions, ribs, ridges, and constrictions. In the embodiments
illustrated in FIGS. 12-14, the sleeve 20 comprises a plurality of
protrusions 120. In other embodiments, continuous annular ribs can
be used in place of the protrusions. Such annular ribs may tend to
buckle when the sleeve is turned inside-out, thus causing ripples
and irregularities in the outer surface of the finally assembled
device. Thus, rows of protrusions 120 such as those illustrated in
FIG. 12 are used in many embodiments to allow the sleeve 20 to lie
more smoothly on the outer surface of the housing 12. The rows are
generally configured such that adjacent protrusions abut one
another without deforming the sleeve 20 when the sleeve 20 is
inverted. Each of the protrusions 120 can have many shapes
including rectangular, circular, and/or elliptical shapes.
[0076] The protrusions 120 can be provided in annular rows
generally configured to correspond to the spaces between the rings
60 of the housing 12. The length of each row is generally also
sized to allow the protrusions to lie between the linear flanges 62
adjacent the slots 46. In other embodiments, the sleeve protrusions
120 and/or the rings 60 and flanges 62 of the housing 12 can be
provided in any pattern of cooperating structures to allow the
sleeve 20 to be retained against axial and/or rotational movement
relative to the housing 12. For example, in some embodiments, the
sleeve 20 further comprises recesses or windows 126 for receiving
and surrounding portions of the housing, such as the Luer
protrusions 70 (see FIG. 1). In other embodiments, as discussed
above with reference to the two-piece housing of FIGS. 7-11, the
housing does not have rings 60, so the flexible member need not
have protrusions (see FIGS. 16-18).
[0077] In the illustrated embodiment, the sleeve 20 comprises a
constriction 122 surrounding the opening 124 of the sleeve 20. The
constriction 122 generally comprises a section of the sleeve with a
reduced diameter as compared to the second section 114. The
constriction 122 can be configured to engage a feature on the
housing 12 such as the annular groove 54 (see e.g. FIGS. 24 and 25)
when the sleeve 20 is inverted over the housing 12. In other
embodiments, the constriction 122 can be configured to engage and
be retained by a space 61 between a first housing portion 41 and a
second housing portion 51 (see FIGS. 10 and 11).
[0078] As described previously, some embodiments of a sleeve 20 can
be provided with one or more windows 126 to accommodate and
surround one or more structures on the housing such as protrusions
70 (also referred to as Luer lugs) or sized to receive a standard
Luer connector. In such embodiments, the windows 126 can be molded
to include thicker edges to prevent undesirable tearing of the
sleeve material during assembly or use.
[0079] Moreover, as previously described, in some embodiments the
sleeve 20 is not formed integrally with the valve member 14. The
sleeve 20 can also be formed by adhering, coating, or otherwise
providing an outside surface on the housing 12 with a suitable
gripping region (instead of mechanically stretching a separately
formed sleeve member over the outside surface of the housing 12).
The sleeve 20 can also be formed as a band or clip that extends
around only the portion of the housing 12 where the fingers of the
health care provider are expected to grip the connector 10. Also,
in certain embodiments, the connector 10 may be constructed without
a sleeve 20.
[0080] In the embodiments depicted in FIGS. 16-18, a flexible
member 81 includes at least one stiffening rib 87 oriented
substantially along a longitudinal axis of the valve member 14 and
protruding transversely to the flat surfaces of the lateral
extensions 84. FIG. 16 illustrates a perspective view of various
embodiments of flexible member 81 including two stiffening ribs 87,
and FIGS. 17 and 18 illustrate cut-away views of the flexible
member 81 of FIG. 16. In the illustrated embodiments, the flexible
member 81 is configured to be assembled with a housing lacking
rings 60 as the flexible member 81 does not include any protrusions
120 (see FIGS. 12-14). In other embodiments, a flexible member can
include both a stiffening rib 87 and protrusions 120 for
application to a housing having rings 60 such as is illustrated in
FIG. 2.
[0081] The stiffening ribs 87 can provide resiliency and durability
to the valve member 14. In some embodiments, the ribs 87 can help
the valve member 14 to resist crumpling in a substantially
longitudinal direction upon insertion of a medical implement into
the slit opening 100. Such crumpling could block or restrict fluid
flow, prevent the connector from closing, or otherwise result in
some degree of inconsistent performance. Since the crumpling
tendency could be exacerbated by aging of a medical connector and
repeated usage cycles, the stiffening ribs can greatly extend the
lifespan of a valve member 14 in a medical connector. In some
embodiments, additional structures and/or materials can be used in
the medical connector 10, either in combination with or absent
stiffening ribs 87, to resist crumpling of the valve member 14. For
example, the valve member 14 may be constructed of a material
selected to be flexible enough to permit insertion of a medical
implement into the slit opening 100, but stiff enough to resist
crumpling over repeated usage cycles. Likewise, a desired balance
between flexibility and valve longevity and resistance to crumpling
may be achieved by selecting a desired thickness of the valve
member 14 (with relatively thicker material used in the valve
member 14 increasing the valve longevity and crumple resistance at
the expense of flexibility and ease of insertion of medical
implements into the slit opening 100). For example, in some
embodiments, the thickness of the wall of the valve member 14
across most, nearly all, or all of its outside surface area can be
about as thick as the wall of the valve member 14 plus a stiffening
rib 87. In some embodiments, the thickness of the wall of the valve
member 14, in at least some regions, is at least as large as, or at
least about 1 1/2-2 times as large as, the diameter of the lead
lumen 102.
[0082] Another embodiment of flexible member 83 for use in a
soft-grip medical connector that is configured to extend the usage
lifespan of a valve member is illustrated in FIGS. 19-21. FIG. 19
illustrates a perspective view of the flexible member 83. As
illustrated in FIG. 19, the flexible member 83 may share many
external features with other embodiments of flexible member 80, 81
as previously discussed (including but not limited to those that
are illustrated in FIGS. 19-21). For example, the flexible member
83 includes a valve member 153 and a sleeve 165. In certain
embodiments, the sleeve 165 includes protrusions 157 for coupling
with corresponding flanges on a housing. The sleeve 165 includes a
constriction 161 surrounding an opening 163. The sleeve can include
one or more windows 159 to accommodate and surround one or more
protrusions 70 or other structures on the housing. The flexible
member includes a transverse flange 155, a neck 167, and lateral
extensions 169. As illustrated in FIGS. 20 and 21, the flexible
member 83 includes a lead lumen 173 having a downstream opening
151.
[0083] As illustrated in FIGS. 20 and 21, which present cut-away
views of the flexible member 83 of FIG. 19, the internal structure
of the embodiments of flexible member 83 illustrated in FIGS. 19-21
can include features absent from other embodiments of flexible
member 80, 81 illustrated herein. The valve member 153 of the
flexible member comprises a pair of opposing sidewalls 177, 179
that intersect at an upstream end of the valve member 153 to form a
slit 171 configured for insertion of a medical implement. In an
undisturbed state, the slit 171 provides a sealed closure of the
medical device to prevent the passage of fluid therethrough. In the
downstream direction, the sidewalls 177, 179 diverge such that in
an undisturbed state, a passage 175 defined by the valve member has
a non-zero volume. Thus, unlike the previously-described flexible
member 80, 81 embodiments, this flexible member 83 does not have a
passage that is substantially planar in an undisturbed state.
[0084] In some embodiments, this non-zero volume of the passage 175
in an undisturbed state can prevent the illustrated embodiment of
flexible member 83 from exhibiting positive flow characteristics
when a medical implement inserted completely into the slit 171 is
removed under certain circumstances. This passage 175 configuration
has certain other advantages. As previously noted, the flexible
member 83 resists crumpling. The divergence of the sidewalls 177,
179 enhances the durability of the valve member 153 as compared
with planar sidewalls of other flexible member 80, 81
embodiments.
[0085] Additionally, the slit 171 of the flexible member 83 has a
relatively small region of contact between the sidewalls 177, 179.
The small region of contact results in a corresponding small
resistance to flow in an undisturbed state. Thus, the flow through
the valve member can be quickly initiated by inserting a medical
implement only partially into the passage, or even merely
positioning the medical implement adjacent to, but not within, the
slit 171. Thus, either the tip of the implement or the pressure of
the fluid flow breaks contact of the sidewalls 177, 179 at the slit
171 to open the valve. Advantageously, where partial insertion of,
or merely adjacent contact with, a medical implement is performed,
the valve member 153 may exhibit positive flow characteristics as
the interior volume of the passage 175 in the undisturbed state is
smaller than the interior volume of the passage 175 in the
partially inserted state.
[0086] Furthermore, if, as in the illustrated flexible member 83,
the passage 175 does not configured to provide positive flow
characteristics on complete insertion of a medical implement, the
passage 175 of the flexible member 83 need not include a region of
relatively larger width. Thus, the passage 175 and the lateral
extensions 169 of the flexible member 83 can be relatively narrow.
Correspondingly, the housing can have a relatively smaller diameter
as compared with a positive flow medical connector. Thus, a
reduction in materials costs and connector weight could be achieved
with a non-positive flow embodiment of flexible member 83.
[0087] Embodiments of methods for making the valve member 14 of the
flexible connectors 80, 81 will now be discussed with reference to
FIGS. 12-18. In general, a valve member 14 for use in the present
system can be made according to any suitable process available to
those of skill in this field. In some advantageous embodiments, the
valve member 14 is built by molding first and second "pre-forms"
130 which are then placed face to face within a second mold. The
pre-forms 130 are then over-molded in a separate molding process to
form an integral flexible member 80 with valve member 14 and sleeve
20 portions such as those shown and described herein.
[0088] In one embodiment, a valve member 14 can be molded according
to the general process described in U.S. Patent Application
Publication No. 2004/0006330. A pair of preforms are molded between
first and second mold pairs. After this initial molding step, the
mold halves with the preforms still positioned therein, are pressed
together with an overmold plate positioned between the mold halves.
The overmold plate is generally configured to produce the final
shape of the valve member 14. With the mold apparatus (including
the preform mold halves and overmold plate) fully assembled,
additional uncured material is then injected into the mold
apparatus to fill the additional space in the mold cavity created
by the overmold plate, thereby forming the remainder of the valve
member 14. In some embodiments, the overmolding method described in
the '330 publication can be adapted to form a valve member 14 with
an integral sleeve as described herein. Alternatively, a valve
member 14 can be molded according to the method of the '330 patent,
and a sleeve 20 can be subsequently joined to the valve member 14
by any suitable process such as molding, welding, or adhesives.
[0089] Another embodiment of an overmolding method is provided with
reference to FIG. 15. According to this method, preforms 130 are
molded and completely removed from their molds prior to performing
an overmolding or joining step. FIG. 15 illustrates one embodiment
of a preform 130 for use in forming a valve member 14. Each preform
130 has a generally planar face 132 that, in the completed valve
member 14, forms a wall of the slit 94. A flange portion 134 is
also integrally molded with each preform 132. The sides of the
flange portion 134 can be set back from the face 132 of the planar
portion in order to provide a space 136 for overmold material to
flow between and connect the flange portions 134 of two preforms
130. The molding of the preforms 130 is typically accomplished by
injecting a thermoset material into the cavity formed between the
mold pairs and heating the molds and/or material to the set
temperature of the specific material used. Pressure may be applied
as needed to prevent material from leaking between the halves of
the preform mold (not shown). In some embodiments, the preforms 130
can be provided with dimples 110 on a back side 138 opposite the
face 132.
[0090] After each preform 130 is molded, it can be removed from the
preform mold and placed into an over-mold. The over-mold is
generally configured to form a final desired valve member/sleeve
structure 80. In some embodiments, an overmold comprises first and
second halves. Each half can comprise pins configured to locate the
preforms 130 in the overmold by aligning the pins with dimples 110
in the preforms 130.
[0091] Once the preforms are properly located in the overmold
halves, the overmold halves can be brought together and an uncured
overmolding material can be injected into the mold cavity. In some
embodiments, the additional (overmolding) material is injected soon
(i.e., a few seconds) after the preforms 130 are molded and while
they are still somewhat hot from their initial molding. The
additional material injected into the mold cavity bonds to the
edges of the preforms 130 and forms the edges of the slit 94 in the
completed valve member 14 and sleeve 20. In this way, the remainder
of the valve member 14 and the sleeve 20 are overmolded and
integrally formed with one another and with a pair of preforms
during the over-molding step.
[0092] In some embodiments, the preforms 130 are pressed together
with sufficient force during the overmolding process to prevent the
overmolding material from migrating between the contacting surfaces
of the preforms 130. This preserves the patency of the slit 94 by
preventing the contacting faces of the preforms 130 from bonding to
each other during the overmold step.
[0093] In other embodiments of this method, additional material is
allowed to flow between and bond the contacting faces of the
preforms to one another. Subsequently, the valve member 14 can be
re-opened by inserting a blade between the preforms, thereby
cutting open the slit 94. In still another embodiment, the entire
valve member/sleeve structure can be molded in a single process
(i.e. without a pre-formed slit), and a slit 94 can be subsequently
formed by inserting a blade into a solid valve member section. In
another alternative embodiment, a sleeve 20 and valve member 14 can
be individually pre-formed and subsequently attached to one
another, such as by overmolding, welding or with adhesives.
[0094] In some embodiments, the material added in the overmold step
is similar to that utilized in molding the preforms 130. However,
in other embodiments the preform material and the overmold material
may comprise different but nonetheless suitable materials for
manufacturing the valve member 14 and sleeve 20.
[0095] In general, the sleeve 20 is typically made of a material
with sufficient flexibility to allow the sleeve 20 to be inverted
and stretched around the housing 12, and sufficient resilience to
tightly grip the housing 12 in the inverted orientation. Similarly,
the valve member 14 is typically made of a material that is
sufficiently flexible to allow a cannula to be inserted therein to
open the slit, and also has sufficient resilience to re-close the
valve member 14 once the cannula is withdrawn. In some embodiments,
the valve member 14 and the sleeve 20 are unitarily formed of an
elastomeric material such as silicone rubber. In one preferred
embodiment, the valve member 14 and sleeve 20 are integrally molded
from 50 durometer silicone rubber. Alternatively, the valve member
14 and sleeve 20 can be made of synthetic polyisoprene, other
silicone rubber and/or urethane formulations, or other materials
acceptable for medical use. In some embodiments, the sleeve 20 can
be molded from a first material, and the valve member 14 can be
molded from a second, different material.
[0096] Some embodiments of a flexible member 83 (FIGS. 19-21) not
including positive flow characteristics can be more efficiently
manufactured. The manufacture of a flexible member 83 as
illustrated in FIGS. 19-21 can be accomplished with fewer steps
and, accordingly, lower costs than other embodiments featuring
positive flow functionality. The relatively small region of contact
between the sidewalls 177, 179 facilitates manufacture of the
flexible member 83 embodiments illustrated in FIGS. 19-21.
[0097] With reference now to FIGS. 22-25, embodiments of a method
of assembling a soft grip medical connector 10 will be described.
The valve member 14 can be inserted into the upper housing cavity
42 portion of the housing 12 by partially folding or compressing
the lateral extensions 84 inwards and pushing the valve member 14
into the upper housing cavity 42 until the compressed or folded
lateral extensions 84 reach the slots 46 and are permitted to
uncompress or unfold and extend through the slots 46 to the outside
of the housing 12. In some embodiments, tooling can be employed to
grasp the lateral extensions 84 and pull the valve member 14 into
the upper housing cavity 42. In some of these embodiments, the tool
can be configured to engage the dimples 110 in the lateral
extensions 84 to grasp and pull the valve member 14. As the lateral
extensions 84 are aligned and pulled or pushed through the slots
46, an additional downward force can be applied to slightly stretch
the valve member 14 and allow the shoulders 92 to engage the top
edges 140 of the slots 46. In this way, a preload (discussed in
further detail below) can be applied to the valve member 14. This
downward force also allows the lead lumen to more securely engage
the interior cannula 50 within the housing 12.
[0098] Once the valve member 14 is fully inserted into the upper
housing 40 (e.g. as shown in FIG. 25), the sleeve portion 20 can be
inverted and stretched over the housing 12. This can be
accomplished using any suitable tooling. The sleeve 20 can also be
grasped by a person's fingers and pulled outwards and downwards in
the direction of the arrows 146 in FIG. 23. As the sleeve 20 is
inverted, the protrusions 120 will generally align with the spaces
between the rings 60 of the housing 12. If provided, the windows
126 will also be aligned with the protrusions 70 so that the
protrusions 70 pass through and extend beyond the flexible member
80.
[0099] When a cleaning solution or other liquid is applied to the
medical connector 10, the liquid may seep around the protrusions 70
between the sleeve 20 and the housing 12, thus causing the sleeve
to slip relative to the housing 12 and making it more difficult for
a health care professional to grip the outside surface of the
medical connector 10. To reduce the risk that the sleeve 20 will
slide or separate from the housing 12, the sleeve 20 can be adhered
to the housing 12. Additionally, in various embodiments, the sleeve
20 may be stretched over an annular groove 54 (FIG. 24) or
sandwiched in a space 61 between housing portions 41, 51 (FIGS. 10,
11) to reduce the risk of slippage. Before the sleeve 20 is
inverted and stretched over the housing 12, an adhesive can be
applied to the housing 12 or the sleeve 20 in a location of contact
between the sleeve 20 and the housing 12 of an assembled connector
10. For example, in certain embodiments, the housing may include a
recess 73 (FIG. 11) adjacent the Luer lugs 71 to which adhesive may
be applied. Alternatively, adhesive may be spread over an outer
surface of the housing 12.
[0100] Preferably, the housing 12, sleeve 20, and adhesive are
chosen of compatible materials to reduce the risk of material
degradation due to the application of adhesive. For example, the
sleeve 20 can be constructed of a silicone rubber, to be bonded
with the housing 12 with a silicone-based adhesive such as an
adhesive comprising dimethylpolysiloxane. In certain embodiments,
the adhesive may require the mixture of two components, at least
one of which includes a catalyst such as a platinum-based catalyst.
In certain embodiments, the adhesive may require curing such as,
for example, by heating the adhesive to a predetermined temperature
for a predetermined time. For material compatibility with a
silicone-based adhesive, the housing 12 can be constructed of a
glass-reinforced thermoplastic polyester resin, such as, for
example, glass-filled Valox.RTM. including approximately 30% glass
fill, produced by General Electric Company. In some embodiments,
the housing 12 can be constructed of a polycarbonate material,
although in some situations the polycarbonate may not be compatible
with a silicone-based adhesive.
[0101] FIGS. 24 and 25 illustrate cross-sectional views of
embodiments of a fully assembled soft grip medical connector 10. In
the illustrated embodiment, the sleeve 20 fully surrounds the
housing 12 including the upper housing 40, the rings 60, and a
substantial portion of the Luer skirt 52. But, it is contemplated
that in other embodiments, the sleeve 20 may extend over a portion
of the housing 12. For example, in certain embodiments, the sleeve
may extend from the upstream end 16 of the housing 12 downward over
between approximately one-half a height of the upper housing 40 and
the entire upper housing 40. In other embodiments, the sleeve 20
may extend from the upstream end 16 of the housing 12 downward over
between approximately one-fourth the height of the upper housing 40
to one-half the height of the upper housing 40. Likewise, in
embodiments of medical connector 10 including a two-piece housing,
as illustrated in FIGS. 7-11, in various embodiments, the sleeve 20
can surround a portion of the first housing portion 41,
substantially all of the first housing portion 41, all of the first
housing portion and a portion of the second housing portion 51, or
all of the first housing portion and substantially all of the
second housing portion 51. The sleeve 20 can also surround the
lateral extensions 84 extending through the slots 46 of the housing
12.
[0102] FIGS. 24 and 25 illustrate an example of an assembled
connector in a sealed state (i.e., in which fluid flow through the
connector is impeded). The valve member 14 is positioned within the
upper housing cavity 42 of the housing 12, with the first and
second lateral extensions 84 of the valve member 14 protruding from
the first and second slots 46 in the housing 12. The lead lumen 102
of the valve member 14 is positioned so that the interior cannula
50 extends at least partway into the lead lumen 102 of the valve
member 14, facilitating fluid communication between the valve
member 14 and the Luer cannula 32 when the connector is in the open
state (as illustrated in FIGS. 15 and 16). The flange 90 covers the
axial opening at the upstream end 16 of the housing 12.
[0103] The sleeve 20 on the outside surface of the housing 12
allows health care providers to more comfortably and effectively
grasp the connector 10. The flexible material of the sleeve 20
provides a softer surface for the fingers. There is preferably a
high-friction interface between the flexible material of the sleeve
20 and the rubber gloves typically worn by health care providers,
requiring less finger-pinching effort to screw the connector 10
onto a catheter or other medical implement and to maintain the
connector 10 in a desired position and orientation during the
connection and fluid-administration processes.
[0104] In addition to providing a soft, easily grippable outer
surface, the sleeve 20 surrounding the exterior of the housing 12
protects the lateral extensions from being pinched or otherwise
undesirably manipulated during handling and use of the connector.
In one embodiment, the valve member 14 and housing 12 are
constructed such that the distance between the upstream end 16 and
the top edges 140 of the slots 46 of the housing 12 is. slightly
larger than the distance between the flange 90 and the shoulders 92
of the lateral extensions 84 of the valve member 14. This
arrangement results in the application of a tensile force or
preload to the valve member 14 between the flange 90 and the
lateral extensions 84.
[0105] The preload arises as the shoulders 92 bear against the top
edges 140 of the housing and the seal flange 90 bears against the
upstream end 16 and/or the shoulder 142 of the axial opening at the
upstream end of the housing. In some embodiments, the preload
causes the flange 90 to assume a slightly bowl-shaped or concave
configuration as the edges of the upstream housing end 16 bear
against the underside of the flange 90. The bowl-shaped flange 90
tends to more tightly pinch closed the slit opening 100 and thus
enhances the ability of the valve member 14 to prevent fluid flow.
The preload also prevents buckling of the valve member 14 along its
longitudinal axis and maintains the sides of the slit 94 in close
proximity to each other along their entire length. The preload thus
promotes a relatively thin slit 94 below the flange 90, which
enhances the sealing performance of the slit 94. In some
embodiments, a distance between the shoulders 92 and the opening
148 of the interior cannula 50 is sized such that the lead lumen
102 of the valve member 14 will be engaged with and sealed to the
interior cannula 50 of the housing 12.
[0106] Referring now to FIGS. 26 and 27, during use of the
connector 10, a cannula 200 of a medical device 202, such a syringe
, can be inserted into the valve member 14 of the connector 10,
thereby opening the valve member 14 to fluid flow 204 between the
medical device 202 and the Luer cannula 32 of the connector 10.
[0107] Before the cannula 200 is inserted, the connector 10 is in a
sealed state (see, e.g., FIGS. 24 and 25). In this state, the slit
94 defines a substantially closed or highly restricted flow path
through the valve member 14. As illustrated in FIG. 16, when the
cannula 200 is inserted through the slit 94, the valve member 14
opens a fluid flow path within the connector 10 while exerting an
inwardly directed force against the cannula 200 of the medical
device 202, preferably forming a tight seal around the
circumference of the cannula 200 to prevent leakage of fluid
through the upstream end of the connector 10. The insertion of the
cannula 200 into the valve member 14 also causes the valve member
14 to stretch in the downstream direction over the interior cannula
50.
[0108] As fluid is injected from the medical device 202, through
the cannula 200, and into the interior space within the valve
member 14, the space between the slits walls 206 increases further
and the slit walls 206 expand further and lengthen further in the
downstream direction. The valve member 14 thus selectively permits
fluid 204 to flow between a medical device 202 on the upstream end
of the connector 10 and a medical implement (not shown) to which
the lower Luer connector 30 is attached.
[0109] As shown in FIGS. 26 and 27, when in an open state, the
connector 10 permits fluid flow 204 that is preferably
substantially unobstructed and linear. This generally allows the
connector to achieve higher flow rates. In some embodiments, the
fluid flow rates through the connector 10 can exceed 600 cubic
centimeters per minute. In addition, the unobstructed and linear
fluid flow 204 interferes less with the inherent qualities of the
flowing fluid 204. For example, if the fluid flow 204 is blood, the
various blood cells and other constituents are less likely to break
down within the illustrated connector 10 as compared to a connector
in which there is a circuitous fluid flow path with fluid
turbulently strikes against hard and/or angular internal
surfaces.
[0110] As the fluid flow 204 diminishes and/or the cannula 200 of
the medical device 202 is withdrawn from the valve member 14, the
slit walls 206 retract and return to their original configuration
to once again define a narrow, restrictive path width between them
(as illustrated, for example, in FIGS. 24 and 25). This retraction
of the slit walls 206 causes the volume within the slit 94 to
decrease to a certain minimum. The retracting action of the slit
walls 206 also forces out the remaining fluid in the area between
the walls 206. As the syringe cannula 200 is being withdrawn, the
displaced fluid cannot flow out of the slit 94 through the upstream
end of the valve member 14 because this space is occupied by the
syringe cannula 200. The resilient narrow neck 97 of the slit 94
preferably blocks any significant flow of fluid between the outer
surface of the cannula 200 and the inner surface of the flexible
member 80 by forming a tight seal around the circumference of the
cannula 200. Thus, the displaced fluid is instead forced downwardly
from the slit 94, through the interior cannula 50 and downwardly
directed cannula 32, and ultimately out of the housing 12. This
advantageously results in automatic positive flow from the
connector 10 toward the patient upon withdrawal of the medical
device 202 from the upstream end of the connector 10, and avoids or
minimizes retrograde fluid flow toward the connector 10 and away
from the patient.
[0111] Although the foregoing description refers to a syringe, it
is contemplated that any type of suitable medical devices may be
joined to either end of the connector 10, such as IV bags, other
connectors, and tubing, for the purposes of fluid transfer or for
any other desired purpose. An auxiliary connector also may be
connected to the soft grip connector, and both connectors can be
placed in fluid communication with a catheter with an end
positioned within a patient. This arrangement can provide several
advantages in situations which call for the use of a unique
auxiliary connector. For example, when it is necessary to replace
or reconfigure fluid lines connected to auxiliary connectors, such
lines may be removed from fluid communication with the catheter
without creating a backflow in the catheter, and replaced with a
similar connector or any other medical implement. In some
embodiments, one such auxiliary connector may be the CLAVE .RTM.
connector sold by ICU Medical, Inc. However, any connector or other
medical implement or device may be placed in fluid communication
with the soft grip connector 10 to introduce fluid to the patient
or to withdraw blood from the patient including, but not limited
to, pierceable connectors, needle-less connectors, medical tubing,
syringes or any other medical implement or device.
[0112] Although certain embodiments and examples have been
described herein, it will be understood by those skilled in the art
that many aspects of the methods and devices shown and described in
the present disclosure may be differently combined and/or modified
to form still further embodiments. For example, the various
embodiments of housing may be interchangeable applied to the
various embodiments of flexible member to achieve multiple
embodiments of soft-grip medical connector. Additionally, it will
be recognized that the methods described herein may be practiced
using any device suitable for performing the recited steps. Such
alternative embodiments and/or uses of the methods and devices
described above and obvious modifications and equivalents thereof
are intended to be within the scope of the present disclosure.
Thus, it is intended that the scope of the present invention should
not be limited by the particular embodiments described above, but
should be determined only by a fair reading of the claims that
follow.
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