APPARATUS FOR STERILE DOCKING OF MALE MEDICAL LINE CONNECTORS
A docking station for maintaining sterilization of temporarily disconnected male medical line connectors. The docking station has a plurality of docking bays, each of which retains an ampule therein containing sterilization fluid and has an access mouth exteriorly exposed when the ampule is secured in its respective bay. The mouth of the ampule is provided with a female medical line connection for temporarily receiving and securing one of the male line connector temporarily disconnected from a patient. A tubular tip and the concentric connection collar of the one of the male medical line connectors is thereby immersed in the sterilization fluid for sterilization while docked.
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This application is a division of U.S. application Ser. No. 12/590,369, filed on 6 Nov. 2009, which is a continuation-in-part of U.S. application Ser. No. 12/074,951, filed on 7 Mar. 2008, and entitled APPARATUS AND METHOD FOR STERILE DOCKING OF MALE MEDICAL LINE CONNECTORS.
FIELD OF THE INVENTIONThe present invention relates to the field of medical liquid administration, and more particularly, to a docking apparatus and method for simultaneously enhancing the sterility, temporary securement and disinfection of disconnected medical infusion tubing during periods of non-use.
BACKGROUND OF THE INVENTIONImprovements in patient safety have been among the primary concerns of many efforts in today's healthcare industry. Healthcare associated infections remain a major area of focus for these efforts. The Center for Disease Control and Prevention cites healthcare associated infections in the top ten leading causes of death in the United States. Annually, healthcare associated infections account for an estimated 1.7 million infections in hospitals, 99,000 associated deaths, and 4.5 to 5.7 billion dollars in added patient care costs.
The reduction of healthcare associated infections depends upon awareness and adherence to aseptic technique when handling medical equipment that comes into direct contact with a patient. Medical equipment is constantly threatened by exposure to surrounding contaminated surfaces. These surfaces contain microorganisms (bacteria) which can easily adhere to the surface of medical equipment. Once contaminated, the medical equipment becomes a danger to the patient and can serve as a silent killer. Healthcare institutions use millions of intravenous catheters each year. These catheters are at risk of contamination by a variety of mechanisms. One such mechanism relates to the contamination of the exposed tip of an intravenous administration set. This particular problem arises when an intravenous infusion line is temporarily disconnected from a patient (a process which can occur multiple times per day for an individual patient). During the time that the infusion line is disconnected from the patient, the exposed tip of the intravenous tubing may contact potential contaminants. These contaminants can then lead to infection within a patient's bloodstream once the infusion tubing is reconnected to the patient.
The critical event in the aforementioned circumstance is the failure to retain the sterility of the infusion tubing tip and failure to adequately disinfect the tip in the instance of inadvertent contamination during the time of disconnect from the patient. This risk is, in part, an unanticipated outcome of the somewhat recent implementation of needle-less intravenous systems. Prior to the introduction of these needle-less systems, healthcare practitioners typically replaced the needle used to connect the infusion tubing to the intravenous tubing with a new sterile, capped needle to prevent contamination when the line was hanging between uses. Currently, many practitioners are not actively considering the risk of contamination and are not taking steps to secure the sterility of the exposed tubing. When efforts are made to maintain the sterility of the exposed tubing tip, these efforts are both cumbersome (and therefore at times skipped over), or they fail due to technical shortcomings.
Safe practice recommendations include the use of aseptic technique when handling medical infusion lines. The aseptic technique, as pertains specifically to intravenous catheters, includes covering the exposed end of intravenous tubing used for intermittent infusions with a sterile cap between uses and to disinfect the cap prior to reattachment to a patient. There currently exists a plain sterile cap for intravenous infusion tubing that is individually packaged. These caps have shortcomings which limit their routine use. Specifically, these caps must be opened from their individual wrappers for use. This process itself can place the cap at risk for infection before it is even placed onto the intravenous tubing as it requires significant manipulation by the practitioner. In addition, the practitioner may not have one of the individual wrappers immediately available when needed. Furthermore, these caps do not accomplish any active disinfection of the intravenous tubing tip surface.
Disinfecting the surfaces of medical equipment with alcohol is a well accepted and established practice. Evidence exists supporting the use of a one minute alcohol immersion as adequate disinfectant technique. Current practice often utilizes alcohol cloth swabs to accomplish the task of disinfecting the surface of medial equipment, including intravenous tubing. This method has faults limiting its use. The exposure of the intravenous tubing tip to the cloth swab of alcohol does not qualify as an immersion technique. Also, the practitioner may be very likely to contaminate the tubing tip with their skin which is surrounding the cloth swab as it is being held. Lastly, the alcohol prep pads containing the cloth swabs may not be immediately available for use at the time of greatest need.
The docking station herein disclosed includes a means to temporarily and safely secure the free tip of intravenous tubing (or any other medical infusion line) while simultaneously disinfecting that same tip. In this way, the device and associated method described will adequately provide a means to maintain the sterility of a reusable intravenous administration set (or other medical infusion line) that has been disconnected from a patient until it is ready to be reattached for future use. In addition, the docking station of the present invention further provides a means for ensuring that the device utilized to temporarily store and sterilize the medical line connectors cannot be reused.
SUMMARY OF THE INVENTIONThe docking station of the present invention for male medical line connectors, such as, but not limited to, IV connectors, indwelling nerve catheters and dialysate connectors, is comprised of a base housing that is securable to a stationary surface and has a plurality of docking bays. Each of the docking bays are dimensioned and contoured for respectively receiving and temporarily retaining capsules or ampules containing sterilization fluid, such an alcohol liquid or gel. Each of the ampules has a chamber therein containing the sterilization fluid and an access mouth which is exteriorly exposed when the ampule is secured in one of the bays. The mouth of the ampule has a female medical line connection, such as a luer lock mechanism, dimensioned and contoured for temporarily receiving and securing a male medical line connector thereto with the tubular tip of the male connector thereby immersed in the sterilization fluid.
When it is time to reconnect the male medical line connector, it is pulled, along with the connected ampule, from the docking station bay by pulling the connected male connector. Thereafter the male connector is disconnected from the ampule for reconnection to the patient and the used ampule is discarded.
A removable sterilization cover may be provided over each of the ampule mouths or each of the bays of the docking station.
The ampules are received respectively in the bays of the docking station by push insert and pull removal. The ampules in a preferred embodiment are respectively received each in a socket provided in the respective bays with a friction fit for retaining the ampules respectively in the bays. This friction fit may also additionally be provided with a snap fit if desired.
The ampules are secured against rotation in the bays whereby the male connectors may be rotatably connected to the respective ampules. To provide this securement against rotation, the ampules and bays have inter-engaging parts whereby the ampules are secured against rotation in the respective bays.
The base housing of the docking station may be slidably received in a holster which in turn is secured to a normally stationary vertical surface, such as an IV pole.
Normally the base will be provided in rows on the base housing and the rows may in addition be designated by color coding to match a corresponding male medical line connector type.
Absorbent material, such as foam, compressible sponge, fiber or fabric, may also be provided in the ampules for absorbing and retaining the sterilization fluid. In addition, the ampule mouths may be sealed with a pierceable membrane for piercing by the tubular tip of the male connector when it is secured to the female connection of the ampule.
To further ensure that an ampule containing sterilization fluid which has already been used once to secure and sterilize a male medical line connector, it cannot be used again the second time, the ampules are secured against rotation in the clockwise direction in their respective bays to facilitate total connections of a male medical line connector, but are, however, permitted to freely rotate in a counterclockwise direction in their respective bays to prevent disconnection of a male medical line connector therefrom while the connected ampule is retained in its respective of said bays. To accomplish this, the ampules and bays have inter-engaging parts whereby the ampules are secured against rotation in the clockwise direction in their respective bays and permitted to freely rotate in the counterclockwise direction. These inter-engaging parts include latterly extending wings provided on the ampules and corresponding recesses in the respective bays receiving the wings. The recesses have ramp surfaces for engaging bottom edges the wings whereby the ampules are forced out of their respective bays when rotated in the counterclockwise direction. This forces the user to remove the respective ampule from its respective bay in the docking station so that the ampule does not remain in the docking station. In this manner, another operator cannot be confused into thinking that the ampule is fresh, sterile and ready to use. It forces the original operator to discard the used ampule. In addition, the respective bays are positioned in respective recesses on the docking station and a removable sterilization seal respectively covers each of the recesses and thereby covers the respective bays with the ampules retained therein. Alternatively, the mouths of the ampules themselves may be covered with removable sterilization seals. This maintains the unused ampules in a sterile condition and also indicates to the operator that the respective bay is sterile and unused.
An additional feature is provided wherein the access mouth for each ampule that contains sterilization fluid is exteriorly exposed when the ampule is retained in its respective bay, and each ampule mouth is provided with a female line connection that is dimensioned and contoured for temporally receiving and securing thereto the male medical line connector such that the tubular tip is not only engaged with the sterilization fluid, but also the exposed end portions of the receded connection collar for the male medical line connector also engage the sterilization fluid whereby all connecting exposed surfaces of the male medical line connector are sterilized when the connector is docked. This embodiment further ensures that when the male medical line connector is reconnected to the patient is in a totally sterile condition. The chamber of each ampule may also include an annular array of inwardly protruding scrubbing finger webs for engaging and scrubbing exterior surfaces of the male connector.
Other objects and advantages appear hereinafter in the following description and claims. The accompany drawings show, for the purpose of exemplification, without limiting the scope of the invention or the appended claims, certain practical embodiments of the present invention wherein:
Referring to the drawings, the docking station 10 is provided for docking male medical line connectors 11. The docking station 10 is comprised of a base housing 12, which in this instance is constructed of transparent plastic.
Base housing 12 is provided with a plurality of docking bays 13, each of which is dimensioned and contoured for respectively receiving and temporarily retaining ampules 14 containing sterilization fluid, liquid or gel alcohol. Each of the ampules 14 have a chamber 15 therein containing the sterilization fluid. The chambers 15 contain a foam liquid or gel absorbent material 16 for absorbing and retaining the sterilization fluid. Ampules 14 are each provided with a mouth 17 having a female medical line connector 18 (luer lock) exteriorly exposed when the ampules 14 are secured in one of the respective bays 13. The female medical line connector 18 is dimensioned and contoured for temporarily receiving and securing a male medical line connector 11 thereto with the tubular tip 20 thereof received in the absorbent material 16 thereby immersing the tip in sterilization fluid.
Dome shaped sterilization covers 21 are removable received over each of the bays 13. The covers 21 are also made of transparent plastic and have tabs 22 extending from a circumferential edge. Tabs 22 are provided with a light adhesive whereby each of the covers 21 may be readily removed individually by gripping the respective tab 22 and peeling it away from the upper surface 23 of base housing 12.
Each of the ampules 14 are received respectively in bays 13 by push insert and pull removal. Ampules 14 are respectively received in a socket 24 provided in each of the bays 13 for retaining the ampules 14 in bays 13 with a friction snap fit.
The ampules 14 are secured against rotation in bays 13 whereby the male connectors 11 may be rotatably connected with a conventional rotational luer lock to the ampules 14 while the ampules 14 remain secured in their respective bays 13. This is accomplished by providing the ampules 14 and the respective bays 13 with inter-engaging parts 25 whereby the ampules 14 are secured against rotation in the bays 13.
These inter-engaging parts 25 consist of wings 26 radially extending from the ampules 14, which in turn are received in corresponding grooves 27 of each bay 13.
The mouths 17 of each ampule 14 are sealed with a pierceable membrane 28 for piercing by the tubular tip 20 of male connector 11 in order to help maintain the internal cavity 15 of ampule 14 in a sterile condition and to also help prevent evaporation of the sterilization fluid, such as alcohol. When membrane 28 is pierced it is caused to annularly penetrate into chamber 15 and thereby secure and maintain absorbent material 16 therein.
The docking station 10 is slidably received in a holster 30, which in turn is removably secured to housing 31, which in turn is secured to a vertical surface or support in the form of IV pole 32. The holster 30, or an extra one thereof, may instead be secured to another or different adjacent surface.
With particular reference to
As is best seen in
Housing 31 is secured to vertical IV pole 32 by means of the clamp 40 which is engaged and disengaged in a conventional fashion by rotating knob 41. Clamp 40 is also provided with an extension 42 for attaching or securing accessories, such as another holster 30.
Each of the bays 13 are provided in rows as indicated and, if desired, each of the rows of the base housing 12 may be designated by a different color coding in order to match a corresponding color coding on male medical line connectors 11 of a different type.
Other than the IV pole 32 and parts of the clamp 40, the entire system may be manufactured of plastics.
Referring next to
Instead of the sterilization sealing domes 21 as illustrated in
Referring next to
The chamber 15 includes an annular array of inwardly protruding scrubbing finger webs 55 for engaging and scrubbing interior surfaces of the tip 20 and the connection collar 52. These scrubbing finger webs 55 are constructed of any suitable material, such as an elastomeric plastic or rubber, absorbing sponge or the like to flexibly engage and scrub the exterior surfaces of the collar 52 and the probe tip 20.
A reservoir of the sterilization fluid may also be retained in the bottom portion of the chamber 15 by compressible sponge 56 as illustrated in
In the embodiment of
Claims
1. A docking station for a male medical line connector including an exposed tubular tip and a receded concentric connection collar, said docking station comprising:
- a base housing having a docking bay dimensioned and contoured for receiving and temporarily retaining an ampule containing sterilization fluid;
- said ampule having a chamber therein containing the sterilization fluid and an access mouth exteriorly exposed when said ampule is retained in said bay, said mouth having a female line connection dimensioned and contoured for temporarily receiving and securing the male medical line connector thereto with the tubular tip and exposed end portions of the connection collar engaged with said sterilization fluid.
2. The docking station of claim 1, said chamber including an annular array of inwardly protruding scrubbing finger webs for engaging and scrubbing exterior surfaces of said tip and connection collar.
3. The docking station of claim 2, including compressible sponge retained in bottom portions of said chamber for absorbing and expelling said sterilization fluid.
4. The docking station of claim 1, including a removable seal covering said mouth.
Type: Application
Filed: Aug 7, 2012
Publication Date: Dec 20, 2012
Applicant: PSI Medical Catheter Care, LLC (Erie, PA)
Inventors: Anthony J. Colantonio (Meadville, PA), Menno D. Jager (Meadville, PA)
Application Number: 13/568,244
International Classification: A61L 2/18 (20060101);