Patent Application
20170027817
This application is for novel convenience kits which are used for both transporting and accessing medical vials from a time when a vial is displaced into a safety enclosing bag, sealed within the bag and not further exposed to an exterior environment through vial and bag disposal. Some preferred parts for the convenience kits are disclosed in U.S. Pat. No. 8,449,521 titled METHODS FOR MAKING AND USING A VIAL SHIELDING CONVENIENCE KIT allowed May 28, 2013 (hereafter referenced as '521). While convenience kits made according to this invention utilize parts from '521, convenience kits, as fully disclosed hereafter, range of uses and effectiveness of resulting convenience kits are not evident from and are vastly improved over convenience kits disclosed in '521.
Generally '521 relates to methods for making and using medical convenience kits and, more specifically, for making convenience kits which have a specific purpose of enclosing a vial to provide a closed system for transferring solutions from vials to IV dispensing systems used in patient drug delivery and especially for drug delivery using medicines which present a hazard when exposed to an open environment. However, methods and apparatus disclosed in '521 for cleaning of an inherently associated vial septum, prior to piercing, permit neither sufficient nor adequate time generally required to transport a capped and enclosed vial without access to (opening) bag contents to expose a wipe for sterilizing the septum prior to piercing. It is within the broader field of sealing, transporting, accessing and perpetually maintaining a medical vial within a closed system throughout a medical procedure and disposal that this present convenient kit finds application.
Philosophically and practically, a medical device, such as that embodying Applicant's invention, to be truly useful in modern contemporary practice must not only be considered safe and efficient, but must also be cost effective. There are many facets of related devices which affect cost effectivity. Such facets include product costs relative to value of treatment made possible by the device, cost of inventorying (e.g. how many parts or stock keeping units (SKU's) are necessary to keep in stock to cover possible uses of the device), risks associated with device use and ability of device makers to meet manufacturing standards established for the safety of a receiving patient. It is for this reason that Applicants have elected to concentrate upon convenience kits assembled from products currently proved and certified as being safe and effective for medical use by manufacturers whose controls and procedures are also certified.
As an example, vial adapters are well known and widely available in contemporary medical commerce. Such vial adapters are available as vented and non-vented models and use of both types fall within the scope of the instant invention. Further, as vial adapters generally are not only used to provide access to vial contents by spiking a vial septum, but also to provide stabilizing flanges or latch arms which latch about cap and neck of a vial to securely affix the vial to the adapter. While such latch arms or stabilizing flanges have proved effective, vial adapters with such appendages must often be customized to meet different vial size requirements. This results in increases in numbers of SKU's required to meet needs of a variety of vial sizes used, increasing cost of handling and inventory. Such problems can be eliminated by finding a way to secure a vial to a vial adapter spike without requiring stabilizing flanges (or latch arms) thereby providing an opportunity to use a vial adapter that has universal application to a large range of vial sizes. Solution for such is disclosed hereafter.
U.S. Pat. No. 8,449,521 B2 ('521), as disclosed above, provides for enclosing and accessing a vial, but has a time limitation between time an associated vial is finally enclosed and when the vial septum can be effectively cleaned for spiking. It is this specific limitation which provides a need for newly devised kits for which this application is introduced.
U.S. Pat. No. 8,485,356 B2 ('356) is a continuation-in-part of '521 disclosing a method for accessing a vial septum swab before finally sealing a vial enclosing bag. [Underlining being for emphasis that the disclosed philosophy for vial enclosure was timely associated with swab exposure.] It is this philosophy which requires a completely different convenience kit, such as the instant invention disclosed herein, to meet more stringent vial enclosure requirements.
U.S. patent application Ser. No. 12/460,470, from which '521 continues-in-part, discloses problems associated with Hazardous Drug Handling and provides inventive solutions for those problems. This patent application incorporates by reference such disclosure and other information relative to specifying configurations for shrouding vials preparatory to drug transfer.
U.S. Pat. No. 7,758,560 B2 issued Jul. 20, 2010 to Edward G. Connell, et al. (“Connell”) and titled HAZARDOUS MATERIAL HANDLING SYSTEM AND METHOD discloses a method and system for handling hazardous materials contained in a vial. The system includes an isolation enclosure having an opening for selectively sealing about a vial; the enclosure being made up of a cap portion and a bag body portion. Inside the enclosure is an extraction member (vial adapter) having a preceding engaging member and a primary engaging member which include a plurality of latch arms for securing the vial to the extraction member in two separate steps taken before and after spiking the vial, respectively.
As seen in
The vial adapter of Connell, referenced as engaging member 34 is taught and claimed to have a plurality of latch arms for engaging a vial when first inserted into enclosure 14 at a first site which is distant from a vial spike such that closure of body portion 16; then, after bag closure, for engaging the vial at a second site whereat the vial is spiked. In this way, the following two things are apparently accomplished: (1) no emissions from spiking are possible until the bag is closed and (2) the vial spike is not inadvertently contaminated by contact with an unsterile vial exterior during vial insertion, a problem which must be solved by any closed vial adapter spiking process. The latching arms, themselves, apparently provide for stabilizing the vial inside an enclosure having a base made of a hard plastic shell.
Connell teaches both a non-vented vial adapter and a vented vial adapter. The valve affixed to outlet port 19 is commonly known as a CLAVE® needleless connector.
Connell further teaches a needleless connector adapter 62 which may be used with a syringe and to the CLAVE® valve to permit flow between the syringe and vial adapter, when attached, and restrict flow from each separated part when adapter 62 is separated from the CLAVE® valve.
U.S. Pat. No. 5,289,858 issued Mar. 1, 1994 to Rich W. Grabenkort (Grabenkort) and titled SYSTEM FOR ACCOMMODATING WITHDRAWAL OF LIQUID FROM A BULK SUPPLY discloses providing a safety enclosure for measuring and transferring liquid from a bulk container to a desired site of use or conveyance. The system is taught to be used with a highly commercially successful Add-Vantage® brand bulk drug reconstitution system sold in the United States. Mixing drug and diluent is taught to be accomplished within the bulk container, which provides a reservoir for the mixture in a bag 20. System 10, the subject of the titled invention, is connected with bag 20 through a connecting means 50 to a conduit 56. Conduit 56 is interrupted by a one-way valve 102 which prevents backflow into bag 20. A syringe is taught to be engaged in communication with conduit 56 through a “Y” connector 108 and a second connecting means 116 which is a valve that is closed when the syringe is separated therefrom.
The “Y” site is further connected to a conduit 132 which is also interrupted by a one-way valve. Conduit 132 is also interrupted by a stopcock 180 which may be switched to direct flow to a waste chamber 140 or to a drug receiving site. It is important to note that stopcock 180 is specifically provided for selection of a conduit to either direct flow from a syringe to a waste container or to the drug receiving site. It is also important to note that, due to the disposition of the one way valves, the syringe may be used as a pump to successively deliver liquid from bag 20 to a delivery site without rotating a pathway selecting member of stopcock 180. Stopcock 180 provides no valvular control of fluid flow between the source reservoir and the syringe during the pumping process.
Prevention of backflow by valve 102 provides the necessity for waste chamber 140, as excess liquid or air drawn into the syringe cannot be returned to bag 20. To provide for opportunity to deliver only a desired dose of liquid from the syringe, any excess fluid drawn into the syringe must be wasted. This is the reason for application of stopcock 180, to provide a selectable pathway to a waste chamber 140 because there is no return pathway to bag 20.
To provide access to bag 20 and other associated parts prior to drug transfer and to provide a flexible safety barrier an invertible bag 80 (i.e. one which may be in a given orientation to provide access to bag 20 and associated parts in one retracted state and extended (turned inside out) to envelop bag 20 and associated parts in another state) is taught and claimed. In this case, a vial 12 is connected to a bag 20 and no fluid is exchanged before bag 20 is inverted. Bag 20 is shown to be sealed about conduits 56 and 132 to provide a closed environment for bag 20 and associated parts once bag 80 is inverted and sealed superiorly. When inverted, the bag 80 is also taught to enclose waste receptacle 140. In
While Connell and Grabenkort both disclose systems and methods for enclosing a source of medication prior to access and delivery of such, problems of numbers of SKU's, fluid (i.e. drug) handling efficiency and development of specialized parts should be considered relative to novelty of Applicant's invention.
In brief summary, this novel invention provides a basis for making and using vial adapter shrouding subsystems which are terminally sealed once a vial is disposed within an integrally associated shroud to provide a closed transfer system thereafter through disposal. Generally, the instant invention as disclosed herein, is a method or process for making and using a device embodied in convenience kit products. Such products are generally combinations of conventional, selected components which have been proved and certified for medical use.
The method for making and using a sealable vial adapter enclosing safety shield subassembly according to the instant invention generally involves the following:
(a) as cited in '521, preferably, a vial adapter, which may be vented or non-vented, having a vial spike for piercing a vial septum on a proximal end and a fluid dispensing portion on the opposite or distal end and also having an installed removable cover for the vial spike. The vial adapter preferably is without a vial securing latch arms or vial attachment flanges, although adapters having such attachment arms may be used within the scope of the invention. As is true of substantially all vial adapters, the fluid dispensing portion is a hollow tube having internal geometry consistent with a female luer fitting and an exterior cylindrical surface distally ending at outwardly protruding flanges structured for mating with a male luer locking connector;
(b) a fluid valving device (such as a needleless connector or a male adapter plug), similar to such a device cited in '521, which has a male luer fitting and a luer locking connector which provides a luer locking interface for flanges and geometry of the female luer fitting of the associated vial adapter;
(c) as disclosed in '521, a hollow cylindrical elastic gasket or collar having an internal diameter which is sized to fit tightly about the outer surface of the vial adapter fluid dispensing portion when relaxed but having sufficient elasticity to be stretched without permanent deformation to be displaced over the flanges at the end of the dispensing portion. The gasket has proximal and distal edges defining a length which is less than the length of the cylindrical outer surface of the dispensing portion and a wall thickness which is sized to interact circumferentially with the male luer locking connector of the fluid valving device; and
(d) a conventional plastic bag which is sealable for perpetual bag closure at an otherwise open end of the bag is preferably employed for the shroud. In convenience kits made according to the instant invention, it is preferable for an associated vial to be introduced into the bag at a safety work site which is remote from a site of use. It should be noted that a bag, as used in '521, cannot be finally sealed until introduction of an exposed swab or until a swab is exposed (see U.S. Pat. No. 8,485,356 B2).
(e) providing a means (preferably a frangible cartridge) for saturating a swab to be used for swabbing (cleaning a vial septum) which can be actuated by manipulation of the exterior of the vial and vial adapter containing bag. It is this feature which sets the instant invention apart from the convenience kits of '521 and '356.
(f) as disclosed in '521, gasket or collar expanding and bag puncture tooling by which the gasket is elastically expanded to be displaced over the dispensing portion flanges (This tooling may comprise a tool having a cone shaped proximal end, a base of the cone being approximately the same diameter as the outward extension of the dispensing portion flanges with the associated point of the cone being blunted for assembler safety, yet sharp enough to pierce a hole in the plastic bag which is displaced over the flanges and about the dispensing portion. On the distal end, this tool preferably has a cylindrical rod portion which is sized and shaped to fit into the female luer orifice of the vial adapter.); and
(g) an assembly fixture upon which the vial adapter may be disposed during assembly, the fixture preferably having complementary slots and holes for stabilizing and releasibly mounting the vial adapter and a breadth and width sized to allow facile displacement of the bag there over.
(h) affixing the swab cartridge to a vial adapter spike cover associated with the vial adapter;
(i) disposing the vial adapter with the swab cartridge affixed to the spike cover onto the assembly fixture oriented to provide access to the dispensing portion;
(j) inserting a portion of the gasket expanding tool into the female luer fitting of the dispensing portion of the vial adapter for use thereof;
(k) using the gasket expanding tool, elastically expand and displace the gasket over the flanges to thereby be disposed in a relaxed state in tight communication with the outer surface of the dispensing portion of the vial adapter at a site where the edge of the gasket closest to the flanges is sufficiently close to the flanges to communicate with a male luer connector later affixed to the flanges (It is preferred to apply adhesive to gasket and dispensing portion to securely affix the gasket to the dispensing portion; however; it is also preferred to use an adhesive which takes sufficient time to cure to permit connecting of an associated male luer connector before the adhesive sets);
(l) displacing the open end of the bag over the fixture such that the end of the bag opposite the open end communicates with the exposed point of the collar expanding tool;
(m) drawing the bag over the point to create a hole in the bag which is sufficiently large to permit the bag to be displaced over the flanges yet which is smaller than the diameter of the cylindrical outer surface of the gasket (It is important to note that when gasket and hole are disposed together, thickness of the gasket at the communicating edge of the gasket should entirely be in communication with the circumferential edge of the hole);
(n) displacing the collar expanding part from the dispensing portion;
(o) disposing the male luer fitting of the fluid valving device into the female luer fitting to make a secure fluid connection;
(p) securely affixing the connector of the male luer fitting in tight communication with the flanges on the dispensing portion, thereby forcing the gasket proximally against frictional forces to assure a sealing interface between luer locking connector, bag and gasket to ensure a seal about the connector and thereby provide a complete subassembly for a convenience kit;
(q) accumulating the subassembly and other parts required for a predetermined medically related procedure and packaging them into a convenience kit; and
(r) sterilizing the convenience kit, preferably using gamma radiation technology.
At this Point Use of Convenience Kits Made According to the Instant Invention Depart from '521 and '356 in Methods of Use and Areas of Application; Examples of which are as Follows:
(s) at a site where hazardous drug vials can be handled with safety, displacing a predetermined vial into the bag;
(t) sealing the bag (which shall be kept closed and sealed) through subassembly disposal;
(u) transporting the subassembly to a site where drug from the vial is to be accessed;
(v) manipulating the exterior of the bag to remove a cover from the septum of the vial;
(w) further manipulate the exterior of the bag to release and appropriately saturate a swab of the swab cartridge with cleaning solution;
(x) swabbing the vial septum; and
(y) spiking the vial to provide access to vial contents through the fluid valving device.
Selection of the type of fluid valve device provided with each convenience kit is dependent upon targeted kit application. Though other fluid valving devices may be used within the scope of the invention, a selected device may be a needleless connector or a male adapter plug. If a needleless connector is used, medical or pharmaceutical use of the device is substantially the same as that of a conventional vial adapter/needleless connector currently commercially available. A male adapter plug is applicable to Operating Room (OR) use.
Convenience kits are specifically designed for use in well defined areas of medical application. Convenient kits made according to the current invention have dramatically different modes and methods of use than those associated with '521. Stated otherwise, a kit made according to disclosure of '521 cannot be effectively used with safety in applications hereafter cited for the present invention.
It is important to note that the shroud, of either '521 and the present invention, provides protection from hazardous material which may be on the outside of the vial, for gas or aerosols emitted upon vial spiking or for leakage and spills due to vial septum or other container failure. However, in an OR application, for example, it is equally as critical that the exterior of the shroud be able to be disposed on a sterile field.
In such systems, to guard against contact with matter on the exterior of a contaminated vial, it is recommended that all actions relative to accessing and drawing fluids from a vial be performed within the safety of the sealed enclosure provided by the shroud. For a latch-arm free vial adapter, vial handling and accessing are quite independent of vial size and form of the valve affixed to the dispensing portion of the vial adapter.
(1) Attaching a measurement syringe (and, as desired, a needleless [and preferably dripless] connector adapter) to the needleless connector;
(2) Drawing and measuring a desired dose sample into the syringe;
(3) Disconnecting the measurement syringe (and needleless connector adapter) from the needleless connector; and
(4) Transporting the dose filled syringe to a site of use. (Note that the above four steps are commonly used in contemporary medical-vial-acquisition devices.)
It is important to note that a disconnection of the assembly from the IV container must be made for delivery of the target IV container to a site of use. For this reason, a connecting device, such as a needleless connector adapter (e.g. a Texium® or Spiros®) or a flush syringe attachment may be provided at the end of the extension set where connection is made with the target IV container to provide safety when disconnecting thereat. A syringe affixed with a needleless connector adapter may be provided as part of a kit for further convenience.
A problem using a vented vial adapter occurs when, through improper use, a gas pathway which provides a conduit for pressure equalization between a volume internal to the vial and ambient conditions outside the vial becomes occluded with liquid. When such occurs, gas pressure cannot be relieved as venting is impeded. Such can result in sufficient pressure build-up within the vial to rupture the filter and release of liquid originally resident in the vial being spilled.
Accordingly, it is a primary object to provide methods for making and using vial adapter enclosing safety shield convenience kits.
It is an important object to utilize a conventional, commercially available vial adapter and other commercially available proved and medically certified components.
It is a primary object to provide a kit and method whereby a vial adapter can be securely and perpetually enclosed within a shroud for any period of time prior to removing a septum cover and spiking the vial to permit vial enclosure prior to transport to a site of use.
It is a critical object to provide a sealable enclosure for the vial adapter such that the vial adapter may be a vented vial adapter.
It is also an important object to provide methods for making and using vial adapter enclosing safety shield convenience kits which do not require vial attachment flanges or latch arms to thereby reduce SKU and kit cost and broaden opportunity for use of conventional vial adapters.
It is a principle object to provide a vial adapter enclosing safety shield convenience kit in which dispensing portions of the vial adapter are directly connected to a fluid communicating device, as is commonly the case for conventional vial adapter/needleless connector interfaces.
It is an object to provide a vial adapter enclosing safety shield convenience kit which utilizes a needleless connector as the fluid communicating device for pharmacy applications.
It is an object to provide a convenience kit which is effective in providing enclosed vial access within an operating room (OR) environment.
It is another object to provide a vial adapter enclosing safety shield convenience kit which utilizes a male adapter plug as the fluid communicating device for OR applications.
It is another principle object to provide a method for sealing a hole in a plastic bag disposed about a fluid dispensing portion of a vial adapter such that the bag, once closed at an entry portal for displacing a vial into the bag, provides a sealed, closed enclosure for safety in vial content access.
It is another important object to provide a method for using a conventional plastic bag as the shield in a vial adapter enclosing safety convenience kit.
It is yet another object to provide a vial adapter enclosing safety shield convenience kit which may be used to access fluid from a vial via a measurement syringe and deliver such fluid to an IV container without disconnecting the syringe from a communicating connection with the vial adapter enclosing safety shield.
It is a consequential object to utilize commercially approved medical parts within the vial adapter enclosing safety convenience kit to assure safety during use.
These and other objects and features of the present invention will be apparent from the detailed description taken with reference to accompanying drawings.
In this description, the term “proximal” generally indicates the segment of the device normally closest to the object of the sentence describing its position. The term distal refers to a segment oppositely disposed. Reference is now made to the embodiments illustrated in
Reference is now made to
Vial adapter 10 also comprises a fluid dispensing portion 20 where through fluids are generally dispensed from a spiked vial. Portion 20 comprises a hollow tubular shape which extends distally to a female luer fitting 22 and associated connecting luer lock flanges 24. Proximal to flanges 24, portion 20 comprises a rounded surface 26 which is generally cylindrical in shape and of predetermined diameter. Exemplary vial adapter 10 may be a B/Braun mini-spike vial adapter product number S4003231 (or S4003400 if purchased before sterilization). It should be noted that most vial adapters have similarly configured dispensing portions.
Reference is now made to
A conventional zippered plastic bag, generally numbered 50, is seen in
Referring again to
To provide stability for assembling common parts of a convenience kit according to '521 or of the instant invention, a stand 70, seen in
One other part which is important in initial steps of an assembly of a convenience kit of the instant invention disclosed herein is a puncture and expander tool 80 seen in
Referring once more to
Next, a plastic bag (such as bag 50 seen in
As seen in
Other connecting devices, other than needleless connector 100 can be used within the scope of the instant invention. In
Formation of the seal about hole 89 in the bag is better seen in
A completed subassembly 130′ with a needleless connector affixed to vial adapter 10 is seen in
Reference is made to
Being able to seal a vial within a bag and not requiring further access to the interior of the bag provides a significant opportunity not only in pharmacy applications, but also in providing closed system drug delivery in operating rooms. If exterior bag sterility is maintained as a vial is displaced therein, and the bag exterior is protected prior to use, an entire assembly can be deposited on a sterile field. Thus, via a convenience kit based upon the instant invention can house a vial with a contaminated exterior and be used to access a drug within the operating room environment whenever procedure requires.
Referring to
Note that vial 192 generally has a vial cap 194 (see
Because vial adapter 10 is without flanges or latch arms for stabilizing a vial, vial adapter 10 may be used with a large variety of vial sizes (independent of vial collar-top size). It is noted that flanges or latch arms are well known in vial handling art to provide support to stabilize a spiked vial. To provide a reasonable substitute for such support, bag 50 is tightly folded about the vial (such as vial 192) may use an elastic band 200 (earlier disclosed in '521). However, similar constraint can be accomplished using a glue dot 202, as seen in
As seen in
Reference is now made to
The invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The present embodiment is therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
