US 20080187460 A1
A closure for a tubular access port in a medical fluid flow line or other container comprises a removable cap for enclosing and sealing the tubular access port. The cap has a closed end wall. The end wall carries an extending poker to facilitate the pushing of an antiseptic-carrying material into a lumen of the access port. The poker has an outer diameter that is less than the inner diameter of the access port. A method of using the poker is also described.
1. A method of disinfecting an access port of a medical fluid flow line or other container, said access port having an open mouth, which comprises:
placing an antiseptic-containing material at or in said open mouth;
inserting a poker into the open mouth, to force at least a portion of the material into the open mouth; and thereafter removing the material and poker from the open mouth.
2. The method of
3. The method of
4. The method of
5. The method of
6. The method of
7. The method of
8. A method of disinfecting an access port of a medical fluid flow line or other container, said access port having an open mouth, which comprises:
placing an antiseptic-containing material at or in said open mouth;
inserting a poker into the open mouth,
via the poker, forcing at least a portion of the material into the open mouth; and
thereafter removing the material and poker from the open mouth.
9. The method of
providing a cap;
proportioning the cap to close said access port; and
providing the poker on the cap.
10. The method of
11. The method of
12. The method of
providing the tubular access port with a lumen; and
the lumen defining a female luer shape.
13. The method of
14. The method of
The present application is a divisional of prior application Ser. No. 11/247,931, filed Oct. 11, 2005.
Tubular access ports are used in medical fluid flow lines and other medical fluid containers such as blood and parenteral solution bags, syringe chambers for administration of liquids, and various tube sets such as hemodialysis arterial and venous sets, plus other extracorporeal blood flow sets, and parenteral solution administration sets. The tubular portion of the access port is designed to receive a mating connector of another device which fits within the lumen of the tubular portion. To preserve sterility prior to use, the tubular access port may have a closure of conventional design, typically a removable, tubular cap comprising an end wall covering the opening of the lumen, a tubular wall fitting around the outer portion of said tubular portion and, also, typically, a male member attached to the inner face of the end wall that fits down into the lumen of said tubular portion. The tubular access ports themselves may be on the end of a branch tubing which connects to a tube set or other medical fluid container, or the access port may be directly carried on main flow tubing of a branch tubing set, a medical solution bag, a cap of another kind of container such as a dialyzer housing, a drip chamber, or the like.
Specifically, such tubular access ports may comprise a simple, open tubular end having a cylindrical lumen, or it may comprise a female luer or luer lock connector. Also, the tubular access port may be of a design as illustrated in U.S. published patent applications 2004/0068238 or 2004/0068239.
Additionally, such tubular access ports may contain any partial or complete wall which is recessed below the outer end of the port, and which partially or completely blocks or bridges a recessed portion of the lumen of the tubular access port, such as a one-way valve, check valve or a three-way rotary valve and the like.
As a problem with these designs, when the access port is opened, sterility of course is lost in the lumen of the access port and any barriers, valves or mechanisms within the flow pathway of the port, and the port should be resterilized or disinfected if it is to be reused. Typically, only the external portions of tubular and non-tubular access ports, for example, the elastomeric surface and outer housing of resealable elastomeric injection sites for needles are disinfected, typically with a conventional alcohol “prep pad”.
In accordance with this invention, a closure is provided for a tubular access port in which disinfection of the lumen of the access port is greatly facilitated at low cost and with great ease, without the need of extra equipment except for, typically, a conventional alcohol “prep pad”, or the like, such pads being generally ubiquitous at clinical and medical facilities.
In accordance with this invention, a closure for a tubular access port in a medical fluid flow line or other container comprises: a removable, tubular cap for enclosing the tubular access port. The cap has a closed end wall, with or without a male member attached to its inner face, while typically the end wall's outer face, in turn, carries an outwardly extending poker to facilitate the pushing of an antiseptic-containing material, typically an alcohol “prep pad”, into a lumen of the access port to disinfect at least that portion of such lumen that will mate with the connector of a connecting device, for example, a syringe. Preferably, the entire recessed lumen or flow path of the access port receives disinfectant including portions proximal to any barrier or valve mechanisms that are recessed in the lumen and may become contaminated with use. The poker has an outer diameter that is less than the inner diameter of the access port, to provide space in the access port lumen for both the poker and the antiseptic-containing material. The antiseptic containing material may comprise fluid or gelled antiseptics, or antiseptic impregnated materials. Any appropriate antiseptic may be used, such as ethyl or isopropyl alcohol.
To practice this invention in some embodiments, an antiseptic-impregnated material may be placed across or in the open lumen of the access port. This material may comprise, a conventional, alcohol-soaked fabric prep pad, typically isopropanol, but, alternatively, it may comprise a small piece of alcohol-soaked cotton, or other woven or non-woven material. Other antiseptics such as povidone iodine may be used, if desired.
The poker, which generally comprises a small, projecting, semi-rigid or rigid stick of circular cross section (or any other desired cross sectional shape), is inserted into the open lumen of the access port, to force at least a portion of the antiseptic-containing material into the same open lumen to come in contact with the lumen wall, thereby coating such wall with the antiseptic. (If there is a recessed wall within the lumen of the access port that at least partially blocks or bridges the lumen, the poker may preferably be long enough such that this wall is coated with disinfectant material also.) There, the antiseptic-containing material is allowed to reside for a desired period of time, sufficient to provide a chosen antimicrobial effect by either fluid contact or gaseous effect. Thereafter, the antiseptic-containing material and poker may be removed from the open mouth, leaving at least a film of antiseptic remaining in at least the lumen of the access port and the access port is ready for connection in aseptic manner with another connector for the transfer of fluid therethrough.
While occupying the access port, the antiseptic and/or the antiseptic-impregnated material and the poker can provide closure and sealing, preventing ingress of infective materials, as well as delaying evaporation, thereby increasing the persistence of the antiseptic causing antimicrobial effect to any infective materials already in the lumen. As an advantage of the method of this invention, at least the antiseptic-impregnated material, and optionally the poker, may remain in the access port for a substantial period of time prior to removal and use of the access port. In other words, the antiseptic impregnated material and poker can be applied, for example, immediately after disconnection of the initial, sterile connection of a device to the access port. Such persistence of antiseptic within the access port can provide a degree of disinfection which is substantially higher than the conventional exposed swabbing of a site immediately before use by accessing with a needle in that the kill time by this invention can be greatly extended, resulting in a much more reliable disinfection without a change of disinfectant. In other words, isopropyl alcohol may be used, but the level of disinfection is significantly raised by the extended period of exposure of the injection site or the like to the isopropyl alcohol, when compared with disinfection of the site immediately before access is effected, as is now the common practice. Thus, this exposure time to the antiseptic may be minutes and even hours between access events.
Typically, the poker is carried on a cap which is proportioned to cover the access port. This cap may be the original cap that is covering and optionally sealing the access port as it comes from the factory, typically maintaining aseptic conditions within the access port, with the poker extending outwardly from the cap. The same cap may be used to cover and optionally close the access port after the access port has been used, for example by connection with, and then disconnection from, a male luer or other tubular connector. In some embodiments, the poker has a length that is at least approximately the length of the tubular access port, to assure that the antiseptic and/or antiseptic-carrying fabric is driven completely into the access port to engage all of the inner surfaces of the lumen.
The tubular access port may define a female luer shape, and may thus be capable of sealing connection with a male luer or luer lock connector.
Furthermore, in some embodiments, the cap may also define an attached, outwardly extending, typically C-shaped projection which is proportioned to releasably grip a component of a fluid flow set that carries the access port, to releasably attach the cap to the flow set, with the cap being spaced from the access port. Thus, while the access port is in use, for example in a connection with a connector such as a male luer or luer lock connector, the cap may be hung onto medical tubing of the fluid flow set, to retain the cap nearby for convenient, subsequent use. Then, when the connection between the access port and the other connector is broken, the cap may be used as described above to again disinfect the access port, making use of an antiseptic and/or antiseptic-soaked material as described above, typically removing the cap from its connection with the medical tubing, and using the (typically) outwardly projecting poker of the cap to force an antiseptic and/or antiseptic-impregnated material fabric into the lumen of the access port.
Accordingly, by this invention, a multiple use cap is provided which can initially close off an access port and optionally hold it in sterile condition, and the same cap may be used in a simple process to exert antimicrobial effect in the lumen of the access port, while serving as a temporary closure for the access port in conjunction with the antiseptic-carrying material, for a desired period of time to provide the desired antimicrobial effect, and longer if desired. Typically, the cap is positioned backwards, with the poker extending into the access port, until such time as the cap and antiseptic impregnated material may be removed. Then, the cap may be inverted, and may reclose the access port once again in a normal manner.
Additionally, for heightened disinfection, prior to replacing the cap on the disinfected access port, the interior of the cap may first be swabbed with the same or other antiseptic-impregnated material or disinfected by the insertion of antiseptic. Thus the inside of the access port, its external opening, and adjacent locking threads, if any, as well as the inner surfaces of its protective cap may be disinfected before or after each use.
The access port may carry a slit diaphragm or any other partial or full barrier at a recessed point within the access port, examples of this being disclosed in the above cited published patent applications.
The invention also comprises a method of disinfecting an access port of a medical fluid flow line or another container, the access port having an open mouth. The method comprises: inserting at least a portion of a fibrous or spongy, antiseptic-impregnated material, or antiseptic oil or gel on or into the open mouth of an access port with the poker of the above invention to disinfect at least some recessed portions of a tubular access port. Thereafter, the poker and antiseptic material or gel can be removed from the open mouth, when a desired degree of disinfection has been achieved, which may be a matter of minutes and even hours as previously discussed. Alternatively, the antiseptic oil or gel may not need removal.
Examples on how this might be accomplished, as stated above, includes any of the steps of: placing an antiseptic-containing material across the open mouth prior to insertion of the poker; placing an antiseptic-containing material over or around the poker of the cap prior to inserting the poker into the open mouth of the access port; wadding up an antiseptic impregnated fabric or fibrous material such as a cotton ball, and placing it into the lumen of the access port, then using the poker to drive it further inwardly; taking a non-woven fabric or cotton ball impregnated with disinfectant and placing it over the opening, followed by using the poker to drive it in; using an alcohol gel as disclosed in U.S. Patent Publication 2005/0042240 (the disclosures of which are incorporated by reference), or a commercial hand sterilizing gel, and placing it at or into the opening of the access port followed by using the poker to push the antiseptic gel into the port and cover internal surfaces; using the alcohol gel or the like to coat the poker and then inserting the poker into the access port without a fibrous or spongy material present.
Additionally, the interior and/or exterior of the cap which carries the poker may be disinfected before or after disinfecting of the access port, making use of a conventional swab or the like, and then replacing the disinfectant cap on the disinfected access port.
Typically, the fibrous or spongy, antiseptic-impregnated material is a separate item, but such material may be attached to the poker or the like. The antiseptic-impregnated fabric or other material may be placed across or in the open mouth, inserting a poker into the open mouth to force at least a portion of the fabric into the open mouth. Thereafter, the fabric and poker can be removed from the open mouth, when the desired degree of disinfection has been achieved.
In the drawings,
Referring to the drawings, a closure 10, in closure cap form for a tubular access port 12 of a medical fluid flow assembly 14 is shown, all being of any known type, but for the novel features of this invention. Medical fluid flow assembly 14 may comprise separate lengths 16 of flexible tubing conventionally sealed into a tubular housing 18, which carries tubular access port 12 having lumen 30 extending through outer end 13 of port 12. Access port 12 (and housing 18) may be of generally conventional design, and is particularly shown to be in the form of a female luer lock connector, having threads 20 or alternatively opposed lugs, to secure a male luer lock connector of another device, for example a syringe, in conventional manner.
Alternatively, closure 10 may be used in conjunction with a corresponding tubular access port that is attached to a solution or blood bag, a drip chamber, a housing, or another kind of medical container. Closure 10 can be seen to define a removable, typically tubular cap for covering tubular access port 12 and optionally sealing lumen 30. Closure cap 10 has a closed end wall 22 and an annular side wall 11 which attaches to the outside of tubular access port 12. Alternatively, attached to end wall 22 is a male member (not shown in
End wall 22, in turn, can carry an outwardly extending poker 24 (i.e. extending in opposite direction from annular wall 11 or the male member). Poker 24 is shown to be tubular in structure for the saving of material in manufacture, but its lumen 28 typically does not extend through closed end wall 22. Alternatively, poker 24 may be solid, and it also may be of square, triangular, or other cross section if desired, rather than being substantially cylindrical. Also, poker 24 may taper if desired.
It can be seen particularly from
In some embodiments, the poker outer diameter is about 0.1-3 mm. less than the inner diameter of lumen 30, preferably about 0.5 to 2 mm. less.
Furthermore, closure cap 10 defines an attached, outwardly extending, typically C-shaped projection 32, which is proportioned to releasably grip medical tubing 16 of fluid flow set 14, as particularly shown in
As shown in
After the male luer or luer lock connector has been used and then disconnected, a fluid transfer having been made, cap 10 may be placed again on access port 12 in a normal manner. However, if and when it is contemplated that access port 12 might be reused, and that it is desirable for aseptic conditions to be provided once again to access port 12, as shown in
Cap 10 and antiseptic impregnated pad 34 may be retained in their access port-closing position shown in
In some embodiments, lumen 30 of tubular access port 12 may also comprise an inner, slit barrier wall or diaphragm 31 (
Then, if and when it is desired to reuse access port 12, closure cap 10 and fabric 34 can be removed, presenting an open access port as in
Subsequent to this, access port 12, if desired, may be again treated in the manner described above for antimicrobial effect, making use of the inverted cap closure 10 and poker 24, plus a new antiseptic-carrying fabric 34. Alternatively, access port 12 may be simply reclosed with closure cap 10, to assume once again the configuration of
This comprises a difference between the prior art and this present invention, in which the portion of poker 24 a used to insert antiseptic material into lumen 30 is of reduced diameter, to make room for antiseptic-impregnated fabric 34 or other antiseptic material, as shown in
Alternately, poker 24 a may be mounted on an optional, larger diameter base 27 such as an annular ring, to provide frictionally or snap-fit abutting surfaces with an optionally slightly recessed outer portion of lumen 30, for temporary securance of connector 12 and cap 41 together. Such base 27 with surmounted poker 24 a may be either outwardly extending or inwardly extending.
As shown in
Cap 50 has been, if desired, previously been carried on female connector 12 b in a manner which is inverted from the position shown in
In this embodiment, poker 24 b is long enough so that it crosses junction 64 within recess 58 between connector 12 b and the flexible, plastic tubing 56 upon which connector 12 b is carried, for antimicrobial effect in that area.
Also, cap 70 carries an annular, proximally extending wall 74 a, which serves to enclose the outer end 76 of female connector 12 b in the position shown. Cap 70 can originally be used to close connector 12 b in the position that is inverted from that shown in
In this particular embodiment, the narrow space between poker 24 c and the inner diameter wall of lumen 30 may be filled with a fluid antiseptic agent 78, which may have been applied as a coating to poker 24 c immediately prior to placement into connector 12 b. Such a fluid material may comprise an oil like Betadine, or a gelled alcohol, for example, similar to those of the previously cited published applications, or it may comprise an antiseptic-impregnated fabric which is permanently attached to poker 24 c. Alternatively, a fabric like fabric 60 may be used.
Poker 92 may be used in the manner previously described with respect to other embodiments of the cap of this invention.
Outer ribs 86 and the flat faces 98 of the periphery of closed end wall 82 are used to improve the gripping characteristics of cap 80, the periphery 98 being a polygon as shown.
Accordingly, by this invention, a closure cap is provided which permits the repeated usage of a tubular access port of a medical fluid flow line or other container, where the closure cap remains accessible and not easily lost, and participates in the antimicrobial treatment of the recessed portions of the access port, as desired, between uses of the port.
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.