The present invention relates generally to enteral syringe packaging equipment and more specifically to an adapter cap incorporating a push-pull valve optimized for use in a fully or partially automated system for preparing patient-specific doses of selected pharmaceutical liquid medication for administration by syringe.
Oral syringes are used to dispense liquids into the mouth. Enteral syringes are used to dispense liquids into the gastro-intestinal tract through a tube. As shown in
Hospital pharmacists prefer to fill just one type of syringe because they typically do not know whether a prescription will ultimately be administered orally or enterally. Another issue of great concern relates to mistaken use of syringes. Syringes intended to be dispensed into the mouth or into an enteral tube can, inadvertently, though rarely, be dispensed into an intravenous (IV) patient port. Such mistakes have caused injury and death to patients. Both of these problems have recently been addressed by the Global Device Suppliers Association (GEDSA). This industry group has introduced new devices referred to as ENFIT™ which include enteral syringes. The ENFIT™ devices are not compatible with luer connections or any other type of small bore medical connectors. This ENFIT™ design prevents the misconnection of enteral syringes to the patient's tubing port. As a result of the GED5A organizations efforts, the International Standards Organization created ISO CD 803069-3 which specifies the safe design for an enteral feeding connection. The new ENFIT™ enteral syringes comply with ISO CD 80369-3, can be used to administer medication orally or enterally, and cannot easily be connected to an incorrect patient tubing port.
As shown in
The tapered tip of the oral syringe (See
To address this problem, a new Push-Pull Valve Adapter (for which this patent application is based) was developed by the Inventors specifically for use with the female luer tip of the enteral syringe (refer to
Prior to filling the syringe, the valve is closed (
The initial design of the enteral syringe tip caused excess liquid to accumulate in the tip of the syringe which caused unacceptable fill accuracy for the smaller size enteral syringes. A new design which incorporates an inner nozzle within the syringe discharge port addressed this problem (
The change in the design of the discharge port of the enteral syringe required a new design for the syringe to medication adapter valve. This design changes obviated the prior art. A new adapter needed to fill both the smaller enteral syringes that had the center nozzle port (
Thus, as shown in
Automated filling systems have been developed by Baxa, Inc., For Health Technologies, Inc., Intelligent Hospital Systems, Applicant National Instruments Co. (see, for example, Applicant's U.S. Ser. No. 13/788,849 filed Mar. 7, 2013 and others for the automated filling of syringes). However, the degree of automation in the hospital pharmacy for the packaging of oral/enteral syringes is limited due to the wide array of different syringes to fill, the different medicine containers to fill them from, and the lack of OEM information on bulk medication containers supplied by OEM manufacturers. Bulk medications are commonly provided in variously sized bottles or containers having threaded screw caps that must be removed and replaced with container-to-syringe adapter caps. Most any attempt at automated filling of any syringes requires a modification to standard manufacturer-supplied medicine containers. Semi-automated and automated filling of syringes requires that the medication container be in the inverted position while the syringe is being filled. It is also necessary that the medication container cap be open during the time that the syringe is being filled, and closed when the syringe has been filled to prevent leakage. Thus, the manufacturer-supplied screw-on caps must be removed and replaced by an adapter cap that allows the syringe to be connected to the medication container. To fill oral syringes it is known to use an adapter cap with an elastomeric valve that allow the syringe tip (
Unfortunately, the elastomeric seal-type adapter cap does not work with enteral syringes which are manufactured in a variety of sizes with differing plunger configurations (
Given the diversity of enteral syringes and medicines available, any semi-automated (or fully-automated) system will need sufficient dexterity to manipulate all the myriad prescription bottles containing the pharmaceuticals to be dispensed as well as variously sized enteral syringes, bringing them together in a controlled environment to quickly and accurately fill and label each syringe and to verify its work as it proceeds in order to avoid errors in the process. Existing adapter caps are incapable of use with enteral syringes that are being filled on an automated or semi-automated basis when the medication container is in the inverted position. Consequently, existing adapter caps do not address the needs of medical institutions desiring a semi-automatic or automatic enteral syringe filling system when the medication container is in the inverted position. In addition, an improved OEM bulk container is needed that includes batch number, expiry date, storage instructions, product name, strength, name of the active ingredient(s), dose form, warning statements, National Drug Code (NDC), requirements to be shaken, refrigerated, protected from light, recalls, etc., e.g., a smart-container that carries the foregoing OEM information with it. The present invention was developed to fill these voids.
To address the need to fill enteral syringes, on a semi-automatic or automated basis, with the medicine container held in the inverted filling position, a push-pull adapter cap is herein disclosed. When filling the syringe the valve is open. After the syringe has been filled the valve is closed. The push-pull valve is open or closed by a mechanical actuator at the automated or semi-automated filling station.
The push-pull adapter cap disclosed herein, when used with an enteral syringe filling system, enables hospital pharmacists to simplify and streamline their task, increasing the number of prescriptions that can be filled in a day, and improving patient safety and care by minimizing medication errors and the consequences that ensue.
In addition, a smart-container for bulk medicine that carries OEM information with it is provided, including batch number, expiry date, storage instructions, product name, strength, name of the active ingredient(s), dose form, warning statements, National Drug Code (NDC), requirements to be shaken, refrigerated, protected from light, recalls, etc. This way, hospital pharmacists seeking to fill oral and enteral syringes with medication on-demand at hospital pharmacies from bulk medication containers supplied by OEM manufacturers have the OEM information at their disposal when filling the syringes, saving considerable time, effort and cost.
The objects, features, and advantages of the present invention will become apparent from the following detailed description of the preferred embodiments and certain modifications thereof when taken together with the accompanying drawings in which like numbers represent like items throughout and in which:
For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the exemplary embodiment illustrated in the drawings and described below. The embodiment disclosed is not intended to be exhaustive or limit the invention to the precise form disclosed in the following detailed description. Rather, the embodiment is chosen and described so that others skilled in the art may utilize its teachings. It will be understood that no limitation of the scope of the invention is thereby intended. The invention includes any alterations and modifications in the illustrated device, the methods of operation, and further applications of the principles of the invention which would normally occur to one skilled in the art to which the invention relates.
Stationary portion 12 comprises an annular body with a central passage 22 there through, the central passage 22 being defined by an inner wall having a specific progression of diametric variations. At one end of the body of stationary portion 12, where stationary portion 12 attaches to the top of the manufacturer-supplied medicine container cap, central passage 22 has a relatively large diameter sized to conform to and receive the nozzle of the manufacturer-supplied medicine container cap as described below with reference to
Central passage 22 continues partially through stationary portion 12 at a relatively constant diameter but then constricts at a shoulder 98 to a smaller diameter sized to accommodate the elastomer poppet 84, as will be described further herein, which protrudes from the distal end of passage 22. The outer wall of stationary portion 12 further comprise two spaced annular flanges 24 separated by an annular groove 26 for alignment with a stationary yoke of the filling station, as further described herein. Similarly, the outer wall of poppet 84 is equipped with two spaced annular flanges 89 separated by an annular groove 88 for alignment with a movable yoke of the filling station, as further described herein.
In operation, when the poppet 84 is fully extracted as seen in
At the distal end of stationary portion 12 the outer diameter of the nozzle is sized to fit inside the female nozzle of a Luer lock oral syringe. The fluted outlet 86 of poppet 84 is configured to receive and conform to the tapered nozzles of most enteral syringes. This particular confirmation is well-suited for attachment to all variety of oral/enteral syringes inclusive of a Luer lock syringe with or without nozzles.
One skilled in the art will understand that other configurations may be used for attachment to other medicine containers. For example, the inner wall of the adapter cap along d2 may be defined by a simple inwardly-threaded connection for screw-insertion onto the threaded container neck. Alternately, the inner wall of the adapter cap 10 along d2 may be formed with a series of integrally formed inwardly-directed circular gripping ribs for gripping the neck of a medicine container by its threads.
Alternatively, the ring may fit outside the medicine container neck using a plurality of inwardly-directed resilient annular ribs 107 to ensure a fluid-tight closure. In this case, as the neck of a medicine container is forced into the central void, the ribs 107 engage the threads on the outside of the neck of the bottle and flex slightly to permit the threads to pass. Once past, the ribs 107 spring back toward their original position and press against the neck to engage the threads and secure the adapter cap 10 to the container. Whether male or female, the flexure of the ribs 107 permits the adapter cap 10 to accommodate size variations in outside neck diameter and thread finish, and create a fluid-tight seal without the need for a specific thread pitch. The foregoing is set forth in more detail in co-pending application Ser. No. 13/788,849 filed Mar. 7, 2013, which is herein incorporated by reference in its entirety.
In addition, molded surface features or textures may be provided on the outer surface of each cap to provide a gripping surface.
It should now be apparent that the above design interfaces with and enables opening and closing the flow of medication to enteral syringes with Luer locks and/or internal slip-nozzles while the medication container is inverted. As such, the time to load and unload, or upright and invert, the medication container between syringe fillings is eliminated. In addition, the medication container can also be shaken in an inverted position before, during or after a syringe filling operation, when the medication so requires.
In addition, a “smart” manufacturer-supplied medication container is herein disclosed for bulk medicine that bears OEM information relevant to the filling process. This way, hospital pharmacists seeking to fill oral and enteral syringes with medication on-demand at hospital pharmacies from bulk medication containers supplied by OEM manufacturers have the OEM information at their disposal when filling the syringes, saving considerable time, effort and cost.
The OEM information relevant to the filling process is preferably provided on the base of the bulk medicine container, by a label or other indicia attached thereto. One skilled in the art will understand that the label/indicia may further comprise a 2D barcode to enable easy tracking of the medication container bearing that cap, or may be an RFID tag or other label. Each barcode (or possibly RFID tag or other label) preferably references the following information:
Batch number
Expiry date
Storage instructions
Product name
Strength
Name of the active ingredient(s)
Dose form
Warning statements
NDC number (National Drug Code)
Does product need to be shaken before use? If so, how often?
Does product need to be refrigerated before use? If so, temp?
Does product need to be protected from light?
Volume of original bulk medication container?
The label/indicia containing the above OEM information is most preferably attached to the bulk medication container when it is filled by the OEM manufacturer. This way, hospital pharmacists seeking to fill oral and enteral syringes with medication on-demand at hospital pharmacies from bulk medication containers supplied by OEM manufacturers have the relevant OEM information at their disposal and can scan it or enter it into the filling system when filling syringes. This way, the OEM data is already in the filling system. This accomplishes the following: 1) avoids the need to log in the medication container at the Hospital Pharmacy and input information into the database; 2) avoids the need to replace the standard medication cap with an adapter cap, inasmuch as the adapted cap can be placed on the container by the OEM manufacturer at the outset, saving labor and avoiding transcription errors by a Pharmacy Technician; 3) saves the cost of the standard medication cap (assuming the aforesaid adapter cap is installed by the OEM manufacturer at the time that it is filled; 4) reduces the possibility of the Pharmacy Technician contaminating the contents of the bulk medication container while replacing the standard medication cap with the adapter cap; and 5) reduces the risk of leakage if the OEM manufacturer installs the adapter cap and then a “leak-proof” seal overtop. None of this would not be possible if the adapter caps are installed by the Pharmacy Technician.
Having now fully set forth the preferred embodiment and certain modifications of the concept underlying the present invention, various other embodiments as well as certain variations and modifications of the embodiments herein shown and described will obviously occur to those skilled in the art upon becoming familiar with said underlying concept. It is to be understood, therefore, that the invention may be practiced otherwise than as specifically set forth in the appended claims.
The present application is a division of U.S. application Ser. No. 15/274,702 filed 2016 Sep. 23.
Number | Date | Country | |
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Parent | 15274702 | Sep 2016 | US |
Child | 16893737 | US |