`
`[191
`
`1111 Patent Number:
`
`4,502,616
`
`Meierhoefer
`
`[45] Date of Patent:
`
`Mar. 5, 1985
`
`
`
`.. 222/107 X
`3,862,684 ' 1/1975 Schmitt ............. .. .
`. 222/541 X
`3,917,120 11/1975 Larenz et al.
`222/541 x
`..
`3,993,223 11/1976 Welker et al.
`4,052,986 10/1977 Scaife ............................ _. 222/541 X
`
`.
`
`[54] SINGLE USE VIAL
`
`[75]
`
`Inventor:
`
`_
`Eugene J.Me1erhoefer,
`Hackettstoun, NJ.
`
`Primary Exam1'ner—David A. Scherbel
`Attorney, Agent, or Firm——Wi11iam E. Hedges
`[57]
`ABSTRACT
`A single use vial is provided in clusters of five or two
`times five separably joined vials. The vials are molded
`and filled with a medicated or non-medicated solution
`and each vial is provided with a converging, planar
`front wa_11_ The vials include an integral dispensing n02-
`zle, having a conduit which can be exposed by remov-
`ing a twist off closure. A common separation strip joins
`the facing side of adjacent vials in the cluster but not the
`twist ‘off closures. The angle of convergence of the front
`wall 15 designed to elevate the conduit above the solu-
`non level when the from wan is pheed upon a horizon-
`tal surface to prevent unwanted dripping prior to use.
`
`2 Claims, 13 Drawing Figures
`
`[73] Assignee‘ Health Care Cmcepts’ Inc"
`Anam“°hy’ NJ‘
`[21] Appl. No.: 337,080
`[22] Ffled:
`Jan‘ 4’ 1982
`[51]
`Int. Cl.3 ....................... .. B67D 5/56; B65D 35/08
`[52] US. Cl. .................................. .. 222/215; 222/129;
`_
`222/541; 604/200
`[58] Field of Search ............................. 206/484.2, 484;
`604/200: 2447 4033 222/94: 1071 129! 143! 206:
`215’ 541
`
`References cited
`_
`_
`S
`U S PATENT ]?OCUME
`128,699
`7/1872 Bostwick ........................... .. 222/173
`2,663,461 12/1953 Brown .............. ..
`. 222/107
`3,128,920 4/1964 Volckening et al.
`..
`. 222/215
`3,552,638
`1/1971 Quackenbush . .. .. .. ..
`. . ... 206/484
`3,717,244 2/1973 Smith ................................ .. 206/484
`
`
`
`NT
`
`[55]
`
`120
`
`
`
`
`Lannett Holdings, Inc. LA
`
`
`
`U.S. Patent Mar. 5, 1985
`
`Sheet 1 of2
`
`4,502,616
`
`
`
`
`
`1
`
`SINGLE USE VIAL
`
`4,502,616
`
`BACKGROUND OF THE INVENTION
`
`The present invention relates generally to the field
`non-reclosable packages, and more particularly is di-
`rected to a novel single use vial suitable for storing and
`dispensing a quantity of either non-preserved or pre-
`served product.
`For certain treatments in the field of respiratory ther-
`apy patient administration sets, or circuits, commmonly
`employ the use of a nebulization device, said device
`incorporating a fluid reservoir to contain the solution or
`medication to be administered. Some of nebulizer reser-
`voirs are fitted with a special medication port, or open-
`ing, through which the solution to be nebulized may be
`added, provided the solution is contained in a package
`that will cooperate with, or fit into the port. If the pack-
`age containing the solution to be nebulized does not fit
`into the medication port then the nebulizer unit, or a
`portion of the circuit, must be partially disassembled in
`order to place the solution in the reservoir. The nebu-
`lizer, or circuit, must then be reassembled prior to use.
`Alternatively, if the solution to be nebulized is pres-
`ented in a container unsuitable for filling the reservoir,
`the solution is usually drawn-up into a syringe for the
`purpose of metering and delivering the solution via the
`medication port, into the reservoir. The nebulizer, ‘or
`circuit, must then be reassembled prior to use. This
`manipulation not only imposes additional cost in opera-
`tor time but incurs the added expense of the syringe and
`needle.
`In the field of nursing and the various facets of patient
`care it
`is frequently necessary to irrigate a patient
`through a tracheal or endotracheal tube. Due to several
`factors, e.g., the position of the patient, position or loca-
`tion of the tube, size of the tube opening, quantity (or
`volume) of irrigation solution required, it has generally
`been necessary to draw-up from another container, the
`solution for irrigation into a bulb type syringe or a nee-
`dle and syringe unit. The above manipulation permits
`the nurse to present the proper quantity of irrigating
`solution in a device capable of performing the task at
`hand. The cost in nursing time as well as the cost of the
`components necessary for the above system is obvious.
`In addition to the above cost and preparation require-
`ments, it has been recorded that in several instances the
`needle through which the irrigation solution was being
`administered inadvertently dislodged from the syringe
`and dropped into the patients throat. Complications
`here are also obvious.
`'
`To respond to some of the many and varied require-
`ments that the demand of better patient care places on
`the container in which medication is presented for ad-
`ministration, a few of which are illustrated above, a
`package, or family of packages that will permit delivery
`of the medication to the instrument being used in the
`patient, or to the patient per se, not only is in order but
`is necessary to support and keep pace with ever improv-
`ing technology and medical practice.
`SUMMARY OF THE INVENTION
`
`The present invention relates generally to the field of
`single use respiratory therapy units as well as small
`volume irrigation units, and more particularly is di-
`rected to a non-reclosable liquid containing package
`including a preferred shoulder-neck-nozzle arrange-
`ment on which is located a self contained opening
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`means which, upon removal, exposes a nozzle of cor-
`rect size and shape designed to facilitate proper dispens-
`ing of the contained liquid.
`The present invention includes a cluster or block of
`separable, individual vials suitable for storing and dis-
`pensing discreet quantities of either medicated or non-
`medicated solutions.
`‘-
`
`Each vial in a block is similarly configured and pref-
`erably includes front and back walls tapered or con-
`verging toward the bottom of the vial to elevate the
`nozzle when the vial is placed upon a table or other
`planer surface whereby the liquid product cannot acci-
`dentally drip from a vial after opening. Each vial is
`provided with a twist off opening key to expose a dis-
`pensing nozzle and orifice. Preferably the nozzle is sized
`to have a positive “locating” feature to fit into the medi-
`cation port of a nebulizer unit, e.g., the Bird nebulizer as
`well as a positive “locating” feature to fit the opening of
`tracheal, or endotrachael tubes so that the contained
`solution can be properly directed into the tube and
`applied directly in a stream to the trachael treatment
`area.
`
`Preferably the clusters of vials are arranged in a block
`of five vials or in a block of two times five vials to
`reduce storage requirements as the vials are used. The
`twist off keys or closures are individually arranged on
`the vials of a block and are not joined so that the open-
`ing of one vial will not open an adjacent vial nor will a
`remaining vial in a block or cluster be opened when one
`end vial is detached. Each vial or ampoule in a block or
`cluster should preferably be fabricated of an FDA ap-
`proved plastic of suitable characteristics to retain
`therein any particular solution selected for storage and
`later application purposes. In the event that the_plastic
`utilized is permeable to moisture and air, e.g., oxygen
`permeation,
`the vial clusters could be stored within
`outer foil, or otherwise non-gas permeable packages to
`thereby protect the stored contents from light and oxy-
`gen or air deterioration. Preferably the protective outer
`packages are swept out with nitrogen in a known proce-
`dure prior to, during, or following placement of the vial
`clusters into the protective outer package to further
`protect against air or oxygen deterioration.
`It will be noted that the design of the ampoules or
`vials is such that when an open vial is placed upon a
`horizontal surface, the taper or incline of the body front
`or rear wall will maintain the dispensing end above the
`surface to thereby tend to preserve the sterile treatment
`of the ampoule. Additionally, the incline of the body
`front or rear walls positions the body opening above the
`level of the liquid contents of the solution in a manner to
`prevent inadvertant spilling or dribbling of the fluid
`contents from the-dispensing orifice of an open vial.
`It is therefore an object of the present invention to
`provide an improved single use vial of the type set
`forth.
`It is another object of the present invention to pro-
`vide a novel, filled single use vial which includes down-
`wardly converging front and back walls and an integral
`twist off key.
`It is another object of the present invention to pro-
`vide a plurality of single use vials which are arranged in
`easily separable blocks or cluster packs.
`It is another object of the present invention to pro-
`vide a novel single use vial including a twist off key
`wherein, the removal of the key exposes a dispensing
`nozzle that is suitable for direct application into the
`
`
`
`4,502,616
`
`3
`entrance orifices of existing respiratory therapy and
`tracheal lavage devices.
`It is another object of the present invention to pro-
`vide a novel single use vial or ampoule that is simple in
`design,
`inexpensive in manfucture and trouble free 5
`when in use.
`Other objects and a fuller understanding of the inven-
`tion will be had by referring to the following descrip-
`tion and claims of a preferred embodiment, taken in
`conjunction with the accompanying drawings, wherein
`like reference characters refer to similar parts through-
`out the several views and in which:
`
`10
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`4
`orderly, compact arrangement for convenient storage
`of a plurality of vials in a cabinet, desk, pocket, etc.
`Preferably, the individual vials 12 are arranged in clus-
`ters 10 of five vials as illustrated or in two time five vial
`clusters to provide for the user both a convenient means
`of storage and transportation and also a rapid account-
`ing of the supply on hand. Each vial contains a known
`quantity of treatment liquid 14, for example, 5.0 ml
`capacity.
`Referring now to FIGS. 3, 4 and 5, it will be seen that
`each vial 12 is upwardly provided with a dispensing
`nozzle 16 which extends forwardly of a cylindrical boss
`or flange 18. The vial 12 is preferably molded or other-
`wise formed to a generally trapazoidal
`longitudinal
`cross sectional configuration (FIG. 6) and includes flat,
`downwardly converging front and rear walls 28, 30.
`The front and rear walls are interconnected by respec-
`tive left and right sidewalls 32, 34 to define a hollow
`interior 40 suitable for retaining a measured quantity of
`medicated or non-medicated treatment liquid 14 there-
`within. The front and rear walls 28, 30 and the sidewalls
`32, 34 converge upwardly and define a narrow neck 20.
`A transistion channel 22 interconnects the neck 20 the
`dispensing _boss or flange 18.
`Still referring to FIGS. 3, 4 and 5, a twist off opening
`key 26 includes a grasping area 42 and an air tight seal
`44 to initially provide a top closure for the vial 12. The
`key 26 is defined from the top of the dispensing nozzle
`16 by a weakened seam 46, which seam is formed when
`the vial 12 is molded or otherwise fabricated. Accord-
`ingly, when it is desired to use the treatment liquid 14
`contained within a vial 12, the opening key 26 is grasped
`by the fingers (not shown) of the user and is twisted
`about the weakened seam 46 until the sealing portion 44
`separates from the dispensing nozzle 16, thereby expos-
`ing the outer end of the dispensing conduit 24. As best
`seen in FIGS. 5 and 6, the dispensing conduit 24 is in
`continuous fluid communication with the interior 40 of
`the vial 12 to permit dispensing of the treatment of the
`liquid 14 after removal of the opening key 26. As best
`seen in FIG. 1, it is noteworthy the the twist off opening
`keys 26 are individually formed and are not intercon-
`nected or otherwise joined so that the opening or re-
`moval of one vial, for example vial 12a, will not cause
`opening of the adjacent vial 12b. The complete separa-
`tion of adjacent opening keys 26 will prevent a vial
`remaining in the block or cluster 10 from inadvertently
`being opened when one vial or ampoule is detached for
`use along a separation strip 36.
`Referring now to FIG. 6, it is noteworthy that when
`a vial opening key 26 is removed and the vial is placed
`upon a flat, horizontal surface 38, such as a table top, the
`flat, tapered shape and orientation of a front wall or rear
`wall 28, 30 will prevent rolling or tipping and will main-
`tain the nozzle 16 and conduit 24 well above the hori-
`zontal surface 38 and out of contact, hence possible
`contamination by contact, with surface 38. Addition-
`ally, the surface 48 of the treatment liquid 14 will be
`maintained below the level of the dispensing conduit 24
`and thus will prevent inadvertant leakage of the treat-
`ment liquid from the vial prior to the intended use.
`Referring now to FIGS. 7 and 8, a modified block or
`cluster 10’ comprising a plurality of individual vials or
`ampoules 50 is illustrated. Each block or cluster 10’
`preferably includes a plurality of five vials or ampoules
`50 or two times five vials or ampoules to thereby re-
`quire a minimum of storing space. These individual vials
`50 are separable one from the other along the scored
`
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`25
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`30
`
`FIG. 1 is an elevational view showing a cluster pack 15
`of five vials or ampoules.
`FIG. 2 is a bottom plan view taken along line 2-2 on
`FIG. 1, looking in the direction of the arrows.
`FIG. 3 is an enlarged, partial, elevational view show-
`ing the opening key in place at the nozzle of a vial.
`FIG. 4 is partial, elevational view similar to FIG. 2
`showing the removable key in phantom lines.
`FIG. 5 is a partial, elevational view sin1ila.r to FIG. 2
`with the key removed and partially broken away to
`expose interior construction details.
`FIG. 6 is a side elevational view of the open vial of
`FIG. 5 resting upon a horizontal surface, and partly
`broken away.
`FIG. 7 is an elevational view of a cluster pack illus-
`trating a modified vial configuration.
`FIG. 8 is a bottom plan view of the cluster of FIG. 7,
`looking from line 8-8.
`FIG. 9 is an enlarged, partial, elevational of the top of
`one of the vials of FIG. 6.
`FIG. 10 is an enlarged, partial elevational view simi- 35
`lar to FIG. 10 showing the opening key in phantom
`lines.
`FIG. 11 is a side elevational view of the vial of FIG.
`10 resting upon a horizontal surface, and partly broken
`away.
`FIG. 12 is an elevational view showing a vial of FIG.
`1 in use with a respiratory therapy treatment device.
`Vials of FIG. 7 are similarily used with a resipiratory
`treatment device.
`FIG. 13 is an elevational view showing a vial of FIG.
`1 in use with a tracheal device (patient areas not shown)
`DESCRIPTION OF THE PREFERRED
`EMBODIMENT OF THE INVENTION
`
`45
`
`Although specific terms are used in the following
`description for the sake of clarity, these terms are in-
`tended to refer only to the particular structure of the
`invention selected for illustration in the drawings, and
`are not intended to define or limit the scope of the in-
`vention.
`Referring now to the drawings, there is illustrated in
`FIGS. 1 and 2 a block or cluster pack 10 comprising a
`plurality of similar, severable, liquid containing vials or
`ampoules 12 such as the cluster of edge connected vials
`12a, 12b, 12c, 12d, 12e. The vials of the block or cluster
`are fabricated of suitable moldable plastic and are simul-
`taneously molded and filled with a medicated or non-
`medicated treatment liquid 14 (FIG. 6) by employing
`existing ampoule fabricating and filling equipment well
`known to those skilled in the art. The individual vials
`12a. 12b, 12c, 1211. 122 are preferably secured along tear
`strips or seams 36 to facilatate separation of individual,
`single service containers. The cluster pack provides an
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`separation lines 36’. The individual vials 50 are prefera-
`bly employed as single use, respiratory therapy units
`and each contains a known quantity of treatment liquid
`14, for example 0.5 ml capacity.
`The modified vials 50 are generally diamond shaped
`in longitudinal cross section (FIG. 11) and include con-
`verging front and rear base surfaces 52, 54 and intercon-
`nected, flat, converging front and rear upper surfaces
`56, 58. The front and rear walls .52, 56 and 54, 58 are
`laterally joined by interconnecting respective left and
`right sidewalls 60, 62 to define hollow interior storage
`spaces 64 for receipt and storage of a measured quantity
`of medicated or non-medicated treatment
`liquid 14
`therewithin. The front and rear upper walls 56, 58 and
`the upper portions of the left and right sidewalls 60, 62
`converge upwardly to define a generally cylindrical
`dipensing neck 66 within which is formed a liquid dis-
`pensing channel 68. The channel 68 is in fluid communi-
`cation with the vial interior 64 to facilitate dispensing of
`the stored treatment liquid 14 in the manner hereinafter
`more fully set forth.
`As best seen in FIGS. 9 and 10, each modified via.l 50
`is provided with a twist off type opening key 26', which
`key includes a grasping portion 42' and a sealing portion
`44’ similar to the key 26 as hereinbefore set forth. By
`twisting the key 26' at the grasping area 42’, the sealing
`section 44' will be separated from the vial dispensing
`neck 66 along the weakened seam 46’ to thus expose the
`outer end of the dispensing channel 68 for fluid dispens-
`ing purposes.
`Referring now to FIG. 11, the modified vial or am-
`poule 50 is illustrated at rest upon a horizontal surface
`38, such as a table top. As illustrated, the opening key
`26' has been removed to expose the end of the dispens-
`ing channel 68. The geometry of the configuration of
`the vial assures that the dispensing nozzle 66 will rest
`well above the surface 38 to prevent possible contamai—
`nation therefrom. One of the front or rear base surfaces
`52, 54 is applied directly upon the table surface 38 in
`stable manner to prevent rolling, tipping or other move-
`ment of the vial 50 until ready for use. In this resting
`position, it will be noted that the liquid surface 48 will
`be maintained within the vial interior surface 54 below
`the open end of the dispensing channel 68 to thereby
`prevent premature dispensing or loss of the treatment
`liquid 14 prior to actual use.
`In order to use a single use vial 12 or 50, an individual
`vial 12, 50 is first removed from its associated cluster or
`pack 10, 10’ by separation along a respective separation
`strip 36, 36'. The opening key 26, 26’ is then twisted or
`otherwise manipulated to sever the key from the respec-
`tive dispensing nozzle 16, 66 along the weakend seam
`46, 46'. Vial 12, when being used in a respiratory ther-
`apy application, can then be applied to a medication
`port 70 of a known type of nebulizer housing generally
`designated 74, for treatment liquid application purposes.
`Preferably, the dispensing nozzles 16, 66 are designed of
`outer diameter and of suitable configuration to be uni-
`versally adaptable for application, at all known nebu-
`lizer medication ports, for example, the port 70 of a
`respiratory therapy treatment unit. The small nozzle 16,
`66 is particularly designed of configuration to fit di-
`rectly within the medication port of the “Bird” brand
`nebulizer. In the case of treatment units for tracheal
`and/or endotracheal devices 76, the vial 12 may be
`directly applied by interfitting the neck 20, down to the
`shoulder of vial 12 into the tracheal device to properly
`align and fit the dispensing nozzle. The small size of the
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`vial dispensing conduit 24 in cooperation with the noz-
`zle 16, permits the treatment liquid to be applied interi-
`orly of the treacheal unit 76 in a positive stream when
`the flat front and rear walls 28, 30 are squeezed. It is
`noteworthy that the fingers of the user never touch the
`dispensing nozzle 16, 66 of either vial configuraton 12,
`50. Therefore, the dispensing channels 24, 68 will re-
`main free from touch contamination after opening since
`the fingers do not touch or otherwise contact the dis-
`pensing channel or orifice.
`Although the invention has been described with a
`certain degree of particularity, it is understood that the
`present disclosure has been made only by way of exam-
`ple and that numerous changes in the details of con-
`struction and the combination and arrangement of parts
`may be resorted to without departing from the spirit
`and scope of the invention.
`What is claimed is:
`
`1. In a single use, non—reclosable vial having a squeez-
`able closed body, an intermediate neck and an initially
`closed dispensing nozzle, said vial containing a medi-
`cated or non-medicated solution to be administered to a
`patient for respiratory therapy; the improvement which
`comprises:
`(a) said nozzle having a circular cross-section and a
`diameter sized to fit snugly in the medication port
`of a Bird nebulizer and into the inner solution-
`receiving port of standard tracheal and endotra-
`cheal devices;
`(b) said neck including a cylindrical flange having a
`diameter larger than the medication port of a Bird
`nebulizer;
`(c) said cylindrical flange being connected to the
`lower substantially cylindrical portion of said neck
`adjacent the body of said vial by an intermediate
`transition channel of reduced diameter; and
`(d) said lower substantially cylindrical portion of the
`neck having a circular cross-section and a diameter
`larger than said reduced diameter and such that it
`fits snugly within the internal diameter of standard
`tracheal and endotracheal devices.
`2. In a single use, non—reclosable vial having a squeez-
`able closed body, an intermediate neck and an initially
`closed dispensing nozzle, said vial containing a medi-
`cated or non-medicated solution to be administered to a
`patient for respiratory therapy; the improvement which
`comprises:
`(a) said nozzle having a circular cross-section and an
`outer diameter such .that it fits directly and snugly
`within the medication port of a Bird nebulizer to
`ensure positive introduction of the solution thereto
`and into the inner solution-receiving port of stan-
`dard tracheal and endotracheal devices;
`(b) said neck including a cylindrical flange which
`abuts the outside of the medication port of said
`Bird nebulizer to prevent over-insertion of the
`nozzle of said vial into said port;
`(c) said cylindrical flange being connected to the
`lower substantially cylindrical portion of the neck
`adjacent the body of said vial by an intermediate
`transition channel of reduced diameter;
`(d) said lower substantially cylindrical portion of the
`neck having a circular cross-section and a diameter
`such that it snugly interfits the internal diameter of
`standard tracheal and endotrocheal devices to
`properly align the dispensing nozzle for positive
`dispensing of said solution therein
`
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`7
`whereby said flange con_1pletely closes and seals the
`medication port of a Bird nebulizer when inserted
`therein in positive'locking engagement; and
`whereby said lower portion of the neck serves to
`ensure that the dispensing nozzle is properly posi-
`
`8
`tioned in a standard tracheal or endotracheal de-
`vice when inserted therein, and prevents over or
`under insertion therein or damage to said nozzle or
`the device in which it is inserted.
`*
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`*
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`*
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