Aseptic female connector

A female tube connector defining a tapered socket having an open, inner end communicating with the lumen of a tube, and a sealing cap proportioned to close the connector and to seal the tapered socket. The sealing cap comprises a cap body and a tapered projection proportioned to sealingly fit within the tapered socket. The projection is carried by the cap body and extends beyond the cap body by a distance to permit the projection to substantially completely occupy the whole length of the tapered socket when the cap is closing the female connector. The projection has an outer surface that carries an antiseptic material, so that upon such closure the interior of the tube connector can be sterilized between uses.

BACKGROUND OF THE INVENTION 
Male and female tube connectors such as luer connectors are commonly used 
in blood and medical solution handling, as well as in many other uses. 
Specifically, such connectors are commonly used in commercially available 
hemodialysis sets and other blood handling sets as access ports for 
medicament infusion or sampling. 
Typically, such connectors respectively comprise a tapered socket and a 
tapered projection that together form a conical surface seal and 
connection. 
Caps are commonly used for female luer connectors, which caps may define a 
threaded skirt for engaging a pair of "ears" projecting outwardly from the 
female connector, while a tapered, projecting portion of the cap extends 
into the conical bore of the luer connector. By the ISO standards, which 
are industry standards that govern the design of commercial medical 
products, the tapered projection of said caps only extends for a total 
length of about 7.5 mm., and about 2.1 mm. beyond the skirt of the cap. 
The ISO dimensions of male and female luer engagement leave a portion of 
the tapered socket of the female tube connector open, thus defining a free 
space in the female connector while the cap is sealing the end of the 
female connector. 
Such female connectors are placed on tube ends, such as the ends of 
branching lines extending outwardly from various blood sets including 
hemodialysis sets. Such branching lines may be used to connect to a source 
of parenteral solution, a source of heparin solution, or a pressure 
monitor, for example. Other access ports comprise the well-known 
elastomeric injection sites which are accessed with a needle. 
Prior to initial removal of the cap, the female connector is sterile, being 
in its as-manufactured condition. However, after removal of the cap and 
use of the connector, the cap can be replaced again, but the female 
connector, and the lumen of the connected tubing, are no longer sterile. 
Despite this fact, at the present time no attempts are generally made in 
clinical use to disinfect the female connectors. It is thought to be 
impractical to sterilize the internal surfaces of the female connector 
sockets, and it is even more difficult to sterilize adjacent lengths of 
the tube interiors which connect with the female connectors. 
Another type of tube connection is provided by needle injection sites. The 
outer surfaces of such injection sites are typically disinfected prior to 
every use. However, such disinfection is relatively ineffective because 
the antiseptic is swabbed on only a few seconds prior to puncture with a 
needle. 
Thus there is a need for a tube connector which can be more reliably 
sterilized between uses. 
By this invention, a closure cap for a female tube connector type of access 
port is provided in which internal sterilization or other antimicrobial 
effect can take place in a more reliable, easy manner. By this invention, 
a female tube connector, and a length of the tubing adjacent thereto, can 
be effectively resterilized between uses, to provide further improvement 
in the aseptic practice of blood handling, parenteral solution 
administration, or the like. 
DESCRIPTION OF THE INVENTION 
In accordance with this invention there is provided a female tube connector 
defining a typically tapered socket and having an open, inner end 
communicating with the lumen of a tube, as is conventional in the prior 
art. A sealing cap is provided, the cap being proportioned to close the 
connector and to seal the tapered socket. 
The sealing cap comprises a cap body and a typically tapered projection 
proportioned to sealingly fit within the tapered socket of the tube 
connector. The projection is carried by the cap body, and extends by a 
distance to permit the projection to substantially occupy the whole length 
of the tapered socket when the cap is closing the female connector, 
contrary to conventional commercial practice. Preferably, the projection 
extends beyond the cap body by a distance of at least about 4 mm. allowing 
the projection to be wiped with, or dipped into, antiseptic solution. 
Thus, the projection preferably has an outer surface that carries an 
antiseptic material, typically a volatile antiseptic material such as 
povidone iodine or alcohol. When the cap closes onto the connector, 
essentially the complete, tapered socket of the connector is in engagement 
with the outer surface of the tapered projection and in contact with 
antiseptic, for improved internal surface sterilization. Also, a small 
portion of antiseptic is pushed inwardly to provide vapor for 
antimicrobial action in the interior of the adjacent tube and rear 
portions of the connector. Since the cap will typically remain in position 
for a period of minutes or more prior to reuse, an adequate dwell time can 
be provided for the antiseptic to exhibit excellent effect. 
Alternatively, other antiseptics may be used if and as desired, such as 
antiseptics that are bonded to the tapered surface of the projection, for 
example a thin silver coating or other antimicrobial agent. 
Preferably, the tapered projection of the cap comprises a closed-end, 
hollow tube, with the closed end being the end which faces away from the 
female connector when the cap is applied, and with the other, outer end of 
the hollow tube of the tapered projection being open. Thus, the tapered 
projection has an increase in flexibility, and is more capable of flexing 
and yielding if it is too long by a matter of thousandths of an inch for 
the tapered socket, and is abutting against a surface such as the end of 
the plastic tube upon which the female connector may be carried. Because 
of this increased softness and flexibility caused by making the projection 
of the cap open-ended, the system is more tolerant of dimensional error in 
manufacturing. 
Also, if desired, the lumen of the tubular, tapered projection may contain 
an antiseptic which may diffuse through the walls of the projection, or 
diffuse out of the open end thereof, to provide an automatic source of 
antiseptic to the system, so that antiseptic does not have to be manually 
applied prior to placing the cap into position. 
Typically, a flexible connection such as a tether may connect the cap and 
the connector, so that the cap is not lost and can always be adjacent to 
the connector for opening and closing as may be desired. Particularly, the 
hinged connection system between a cap and a connector as defined in 
Utterberg U.S. Pat. No. 5,385,372 may be used, the disclosures of which 
are incorporated by reference herein. 
Also, it is preferred for the female connector of this invention to carry a 
tube clamp to selectively seal and to open the tube which carries the 
female connector at a flexible portion of the tube adjacent to such 
connector. Squeeze-type tube clamps of many different designs are known. 
Such a clamp may be integrally co-molded with the connector to provide a 
single, integral piece, if desired. 
An advantage of this lies in the fact that the clamping of the tube takes 
place adjacent to the female connector. Thus, after such sealing with the 
clamp, the internal volume defined by the closed clamp and a small length 
of the tubing is both small and quantitatively defined. That entire sealed 
area will be exposed to a volatile antiseptic (if such is used) for a 
length of time between the closing of the connector and its next reopening 
for subsequent use. Such a dwell time of minutes or hours can be adequate 
for a relatively small amount of antiseptic to have highly effective 
antimicrobial effect on the enclosed internal area of the connector and a 
small portion of the tubing interior between the cap and the squeeze clamp 
carried by the female connector in preferred embodiments of this 
invention. This antisepsis provides not only an improvement on the use of 
prior art female luer access ports and caps, but also provides an 
improvement on the use of known needle injection site access ports.

DESCRIPTION OF SPECIFIC EMBODIMENTS 
Referring to the drawings, FIG. 1 shows a female luer connector 10 of 
generally conventional design except as otherwise shown herein, having a 
conically tapered socket 16. 
Luer connector 10 connects with conventional flexible tubing 12 as shown in 
FIG. 2, for example branch tubing extending out from the main tubing of an 
arterial or a venous set for hemodialysis. Alternatively, female luer 10 
may connect one of the main ends of such a hemodialysis set or other blood 
handling set. Tubing 12 may be sealed into bore 14 of connector 10, which 
is typically cylindrical and not tapered. 
Female connector 10 as shown is integrally molded with and connected to a 
pressure clamp 18, which comprises a clamp body 20, an upstanding tube 
guide and first latch 22, having an aperture 24 through which tubing 12 
extends, and a pivotable clamp pressure member 26, having a downwardly 
extending projection 28 to close off the lumen of tube 12 when the clamp 
is in closed position as shown in FIG. 3. Pressure member 26 also carries 
a second latch 30 to latch with the first latch 22 as also shown in FIG. 
3. Thus, the user can open or close flow through tubing 12 by the integral 
pressure clamp 18 carried by female connector 10. First latch 22 may be 
manually pivoted out of engagement with second latch 30, to open the clamp 
again. 
Luer connector 10 may also be integrally co-molded with a closure cap 32 
and a flexible tether or arm 34. Alternatively, cap 32 and tether 34 may 
be added as a separate part. Cap 32 is tethered in adjacent relation with 
female luer connector 10, being capable of entering into closing relation 
therewith as shown in FIG. 3. 
Cap 32 comprises a cap body 36, and a tapered projection 38, which is 
proportioned to sealingly fit within tapered socket 16. 
In accordance with this invention, projection 38 extends beyond the cap 
body 36 and the skirt 37 defined thereby, generally by at least about 4 
mm. and typically 7-10 mm., to permit projection 38 to substantially 
completely occupy the whole length of tapered socket 16 of female 
connector 10 when cap 32 is closing the female connector. Tapered 
projection 38 may have an outer surface 40 which is coated with an 
antiseptic, for example by coating with a volatile antiseptic such as 
povidone iodine or alcohol immediately prior to closure. Projection 38 
then extends substantially the entire length of tapered bore 16 in the 
closed configuration, extending for example to tapered bore end 42 in FIG. 
4, up to bore 14 which carries tubing 12. The antiseptic is thus pressed 
against substantially the entire surface of bore 16, while vapors will 
spread and be retained by the closed cap 32 at one end of female connector 
10. At the other end of the female connector 10, clamp 18 can be closed to 
seal tubing 12 at position 44, resulting in a small, enclosed lumen space 
46 between position 44 and the inner end of projection 38 (at or near line 
42). This inner volume 46 is small, and of a generally predictable volume 
for each specific system designed in accordance with this invention. 
Antiseptic vapors will migrate from tapered projection 38 into this small 
volume to provide sterilization of the surfaces exposed within volume 46 
after exposure of a few minutes to the antiseptic vapors. 
Thus, the connector of this invention can be used to resterilize female 
connectors after they have been used, for a significant improvement in the 
aseptic procedure of blood handling, whereas in the prior art, the 
interiors of female connectors are rarely sterilized between initial use 
and reuse. 
Preferably, tapered projection 38 is a tube, closed at its inner end 48 
within cap body 36 which faces away from connector 10 when the cap 32 is 
applied, and open at its outer end 39 which extends beyond cap body 36. 
The resulting lumen 52 of hollow projection 38 may be filled with 
antiseptic if desired to provide a continuing sterilization effect to the 
sealed interior 46. 
It is also preferred for tapered projection 38 to extend at least about 4 
mm., and typically at least 5 mm., outwardly beyond skirt 37 of the cap 
body, as shown. In the prior art, such a tapered sealing projection of 
luer caps projects outwardly only about 2.1 mm. beyond the skirt, in 
accordance with the ISO standards. 
The strap or tether 34 may be a flexible strap of conventional design. If 
strap 34 is pivotally attached to female connector 10 or to cap 32, then 
skirt 37 of cap 32 can be threaded to engage the ears or projections 54 of 
female connector 10 in conventional manner. If strap 34 is integrally 
molded with connector 10 and clamp 18, then cap 32 will not have threads, 
and will connect to connector 10 with a friction fit in normal 
circumstances. 
The above has been offered for illustrative purposes only, and is not 
intended to limit the scope of the invention of this application, which is 
as defined in the claims below.