`
`aa UK Patent Application 11GB «2384431 «A
`
`(43) Date of A Publication 30.07.2003
`
`(51)
`
`(56) Documents Cited
`GB 1225495 A
`WO 1992/019297 A1
`
`EP 0554996 A1
`JP 2001212237 A
`
`
`
`
`{21) Application No 0201717.6
`INT CL?
`,
`A61M 5/30
`
`
`(22) Date of Filing 25.01.2002
` (52) UK CL (Edition V)
`ASR RCJ
`(71) Appticant(s)
`The Medical Houseple
`
`(Incorporated in the United Kingdom)
`
`201 Newhall Road, Attercliffe, SHEFFIELD,
`S9 2QJ, United Kingdom
`
`(58) Field of Search
`UK CL (Edition T ) ASR RCJ RCR
`
`iNT CL? A61M 5/00 5/31
`Other:
`
`(74) Agent and/or Address for Service
`ONLINE:WPIEPODOC,JAPIO,TXTUSO,TXTUS1,
`Harrison Goddard Foote
`
`TXTUS2,TXTUS3,TXTEP1,TXTGB1,TXTWO1
`Fountain Precinct, Leopold Street,
`
` SHEFFIELD, S1 20D, United Kingdom
`
`
`
`(72)
`
`Inventor(s)
`Kevin Stamp
`
`(54) Abstract Title
`Needieless injector having an audible dose indicator
`
`(57) A needleless injector includes an elongate main body 2, a dosage drum 4 twistable about a longitudinal
`axis of the main body 2 to load a doseinto the injector and an audible dosage mechanism arrangedto emit an
`indication of the quantity being loaded in the form of audible clicks. After rotating the drum 4 clockwise as far
`as possibleto primethe injector, a required dose maybe loadedby rotating the drum 4 anti-clockwise. A
`pickup ring 30 locked to the drum 4 has tags 32,33 which click over successive teeth 21 of a ratchet ring 20,
`internal teeth 22,23 of which cooperate with slots 11,12 in an insert 10 fixed to the main body 2 to prevent
`
`anti-clockwise rotation with the ring 30, each click audibly indicating loading of a specific volume of dose.
`
`At least one drawing originally filed was informal and the print reproducedhereis taken fromalaterfiled formal copy.
`This print takes account of replacement documents submitted after the date offiling to enable the application to comply
`with the formal requirementsofthe Patents Rules 1995
`
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`2384431
`
`NEEDLELESS INJECTOR
`
`needleless
`field of
`the
`to
`relates
`invention
`This
`injectors of the type used,
`for example,
`for subcutaneous
`injection of
`insulin,
`in particular
`a dosage mechanism
`therefor.
`
`Needle-free injection devices or needleless injectors are
`designed to deliver a predetermined dose of a drug,
`for
`example
`insulin,
`by means of
`a
`spring-loaded or gas-
`powered syringe.
`One typical such needleless injector is
`described in US 5,782,802 [Vitajet Corp].
`
`The device described in US 5,782,802 is designed to be
`easily refilled and reused by a Single user with the
`correct dose of a medicament
`required at each injection.
`The device comprises basically of:
`
`a
`
`transparent
`comprising
`head
`injection
`a) an
`nozzle
`and
`a
`cylindrical
`generally
`thermoplastic
`thermoplastic piston tip, both supplied to the user in
`a sterile pack;
`b) a spring-powered unit with means to quickly attach and
`detach the
`injection head from this
`spring-powered
`unit; and
`
`(containing the medicament)
`c) a pre-filled special vial
`which connects to the injection head, or alternatively
`an
`adaptor which
`is
`attached to
`a
`commercially-
`available vial of medicament.
`
`loaded into the device of US
`is
`A dose of medicament
`5,782,802 by turning a dosage drum in an anti-clockwise
`direction so as to draw a quantity of medicament
`into the
`nozzle.
`The user sets the dose by reading two dosage
`scales
`(at
`the same time)
`~- a main scale on the body of
`the device which represents dose increments of 10 units
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`
`
`.408
`
`ooee
`
`2
`
`and a circular scale on the dosage drum which represents
`increments of 1 unit.
`The readings from both scales need
`
`to be added to determine the total dose.
`
`Since the scales are necessarily printed in relatively
`small
`type
`on
`the device,
`there
`is
`a
`risk that
`a
`visually-impaired user may
`set
`the
`dose
`incorrectly.
`Furthermore,
`a user having poor hand-eye coordination may
`also have difficulty in setting the dose correctly and,
`for all users, confusion may arise by the need to read
`
`two scales simultaneously.
`
`There is thus a need for a needleless injector having a
`dosage mechanism which reduces the risk of the dose being
`incorrectly set.
`It
`is
`an object
`of
`the present
`invention
`to
`provide
`a
`needleless
`injector which
`alleviates the above-mentioned problems.
`
`invéntion there is provided a
`According to the present
`needleless injector
`including an elongate main body,
`a
`dosage drum twistable about a longitudinal axis of said
`main body and an audible dosage mechanism, wherein the
`audible dosage mechanism is arranged to emit an audible
`indication of a dose being loaded into the injector.
`
`Preferably,
`
`the dosage mechanism is
`
`arranged to emit
`
`audible clicks.
`
`The audible clicks provide a visually-impaired user with
`a clear
`indication of
`the dose being loaded into the
`injector,
`thus
`reducing their
`reliance on
`reading a
`printed scale.
`Each click can be arranged to indicate a
`fixed quantity of the dose,
`for example one unit.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`In a preferred embodiment,
`
`the audible dosage mechanism
`
`
`
`a
`
`e
`
`°
`
`*
`
`e
`
`te
`
`va
`
`tae
`
`3
`
`comprises a ratchet ring having a plurality of equispaced
`ratchet
`teeth and at
`least one tag which,
`in use, moves
`over said ratchet teeth so as to generate audible clicks.
`The
`spacing of
`the ratchet
`teeth can be set
`so as
`to
`indicate a fixed quantity of the dose.
`The volume of the
`click can be increased by providing a second tag (or even
`more
`than two tags),
`for example, with the second tag
`being placed adjacent
`the ratchet
`ring at
`180 degrees
`from the first tag.
`
`to said dosage
`Preferably, said tag is fixed with respect
`drum so that said twisting of
`the dosage drum causes the
`tag to move over the ratchet teeth.
`
`indication is only
`the audible
`In a preferred form,
`generated when the dosage drum is twisted in an anti-
`Clockwise direction.
`This
`reduces
`the
`likelihood of
`confusion by the user as
`to which way
`the dosage drum
`should be twisted in order
`té6
`load the injector with a
`dose of a drug.
`
`Preferably, said ratchet teeth and said tag are shaped so
`that,
`when
`the
`tag
`is moved
`in
`an
`anti-clockwise
`direction with respect
`to one of said ratchet
`teeth,
`the
`tag passes over said one of said ratchet
`teeth and drops
`onto an adjacent ratchet tooth,
`thus emitting an audible
`click.
`
`teeth and said tag are shaped so
`said ratchet
`Ideally,
`that, when the tag is moved in a clockwise direction with
`respect
`to one of said ratchet
`teeth,
`the tag abuts
`a
`bluff
`end of
`an adjacent
`ratchet
`tooth,
`can move
`no
`further with respect
`to the
`ratchet
`teeth and hence
`“picks
`up”
`the ratchet
`ring which continues
`to move
`together with the tag in a clockwise direction.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`
`
`2068
`
`ring further comprises
`said ratchet
`Further preferably,
`tooth which, when
`the
`at
`least
`one
`internal
`ratchet
`clockwise
`direction,
`a_
`ratchet
`ring
`is moved
`in
`periodically passes over
`a detent which is fixed with
`respect
`to the main body of the injector so as to emit an
`audible click.
`In this way, an audible indication can be
`given to the user that
`the injector is being primed,
`i.e.
`when the dosage drum is twisted in a clockwise direction.
`The
`relatively slow frequency
`of
`clicks which
`are
`generated in a clockwise direction avoids confusion with
`the
`relatively fast
`frequency
`of
`clicks which
`are
`generated
`in
`an
`anti-clockwise
`direction when
`the
`injector is being loaded with a dose.
`
`said dosage drum is provided
`In a preferred embodiment,
`with a window through which a single number representing
`the dose
`currently loaded into the
`injector
`can
`be
`viewed.
`Ideally,
`said window comprises
`a magnifying
`
`10
`
`15
`
`20
`
`lens.
`
`25
`
`30
`
`is part of a spiral scale printed
`Preferably, said number
`In a preferred form the injector
`on said main body.
`further
`comprises means
`for
`generating
`a
`verbal
`indication of said number.
`
`now
`invention will
`the present
`Preferred embodiments of
`be more particularly described, by way of example only,
`with reference to the accompanying drawings wherein:
`
`Figure 1
`
`is a perspective view of a needleless injector;
`
`Figure 2
`
`is a side view of the injector of Figure 1;
`
`35
`
`Figure 3
`
`is an exploded perspective view of the audible
`
`
`
`tae
`
`“Hee
`
`%
`
`dosage mechanism;
`
`is an assembled perspective view of the Figure 3
`Figure 4
`mechanism;
`
`is a perspective view showing the interior of
`Figure 5
`part of the dosage drum;
`
`is a perspective view of
`Figure 6
`to a larger scale; and
`
`10
`
`the dosage drum, drawn
`
`schematic perspective view showing the
`a
`is
`7
`Figure
`dosage values printed on the rearward end of
`the main
`body.
`
`15
`
`20
`
`25
`
`30
`
`35
`
`the term “forward” refers to
`Throughout this description,
`a direction toward the person who
`is
`injected by the
`device and “rearward” refers’to a direction away from
`this person.
`
`Although the preferred embodiment described below relates
`to a spring-powered needleless injector, other
`types of
`needleless injector may be encompassed by the invention.
`The invention is applicable in any injection device which
`requires the dose to be set by the user.
`
`a needleless
`2,
`and
`1
`Referring generally to Figures
`injector
`1 comprises
`an elongate main body 2, at
`the
`forward end of which is a nozzle
`(not
`shown)
`covered,
`when the injector is not
`in use, by an end cap 3.
`
`the main body there is a dosage
`the rearward end of
`At
`drum 4, having winding wings or other protrusions 5 which
`facilitate clockwise or anticlockwise twisting of
`the
`
`
`
`a ft
`
`6
`
`to the main body 2 and which
`dosage drum 4 with respect
`improve the user’s grip thereon.
`
`through
`drum 4,
`the dosage
`is provided on
`A window 6
`which a user can read a scale indicating the dose of
`a
`drug loaded into the injector.
`This will be described in
`more detail below.
`
`is situated on the rearward end of
`A discharge button 7
`the dosage drum 4 and is used to effect delivery of the
`
`10
`
`drug into the user.
`
`is
`
`is held firmly in a
`1
`injector
`the
`In normal use,
`vertical position and the dosage drum 4
`is twisted as far
`as possible in a clockwise direction.
`A dose can then be
`loaded into the
`injector
`from a vial of
`the drug by
`twisting the dosage drum 4
`in an anti-clockwise direction
`whilst observing the scale through the window 6.
`
`20
`
`is
`the dose
`loaded,
`been
`has
`the correct dose
`Once
`delivered into the user
`upon pressing the discharge
`
`button 7.
`
`The needleless injector described herein is provided with
`an audible dosage mechanism which assists the user
`in
`loading
`the
`correct
`dose
`into the
`injector.
`‘The
`components of
`the audible dosage mechanism are shown in
`Figures 3 and 4.
`
`the rearward end of the main body
`Referring to Figure 3,
`2
`is provided with an internally-threaded insert 10 which
`has two slots 11,
`12 therein,
`located 180 degrees apart.
`The
`rearward part of
`the threaded insert
`is surrounded
`(when assembled) by a ratchet ring 20 which has external
`ratchet
`teeth 21 whose bluff ends 21A point
`in an anti-
`
`25
`
`30
`
`35
`
`
`
`7
`
`12
`the slots 11,
`When assembled,
`clockwise direction.
`lie adjacent
`the ratchet
`teeth 21.
`The ratchet ring 20
`also has
`two internal
`ratchet
`teeth 22,
`23 which are
`located 180 degrees apart.
`The
`ratchet
`ring 20
`is
`Surrounded (when assembled) by a ratchet pickup ring 30.
`
`is provided with four orthogonally-
`The pickup ring 30
`located splines
`31 which, when
`the injector
`is
`fully
`assembled,
`locate into four orthogonally-located grooves
`41
`on
`the
`internal
`surface
`of
`the
`dosage
`drum 4
`(illustrated in Figure 5).
`Thus
`the pickup ring 30 is
`rotationally fixed with respect
`to the dosage drum 4,
`The pickup ring is also provided with two depressed tags
`32,
`33 which are located at 180 degrees to one another
`and which can interact with
`(i.e.
`“pick up”)
`ratchet
`teeth 21 on the ratchet ring 20. Alternatively,
`the tags
`32, 33 may be integrally-formed with the dosage drum 4 as
`an alternative to using a pickup ring as described above.
`
`the
`inside.
`friction fit
`is a
`10
`threaded insert
`The
`rearward end of the main body 2 so that the insert 10 is
`rotationally fixed with respect
`to the main body 2.
`In an
`alternative embodiment
`(not
`illustrated),
`the threaded
`insert
`10 may be replaced by an integrally-moulded part
`of
`the rearward end of
`the main body having an internal
`thread and two 180 degree spaced detents which serve the
`same function as slots 11, 12.
`
`is rotationally fixed
`the pickup ring 30
`summarise,
`To
`The threaded insert
`to the dosage drum 4.
`with respect
`to the main body 2.
`10 is rotationally fixed with respect
`The ratchet
`ring 20
`(which sits intermediate the two)
`is
`rotatable with respect to both in either direction.
`
`10
`
`15
`
`20
`
`29
`
`30
`
`35
`
`When
`
`the
`
`dosage
`
`drum 4
`
`is
`
`twisted in a
`
`clockwise
`
`
`
`'a
`
`oe
`to
`
`also rotate in a
`the pickup ring 30 must
`direction,
`clockwise direction by virtue of the interlocking splines
`31 and grooves 41.
`The tags 32,
`33 each abut
`the bluff
`end 21A of a ratchet
`tooth, causing the ratchet ring 20
`to rotate synchronously with the pickup ring 30
`and
`dosage drum 4
`in an anti-clockwise direction.
`Every 180
`degrees,
`the internal
`ratchet
`teeth 22,
`23 catch in the
`slots 11, 12,
`causing a clearly audible “click”.
`This
`relatively slow clicking sound indicates to the user that
`the injector
`is being primed,
`ready for
`a dose
`to be
`
`loaded.
`
`Once the injector is primed (i.e. by rotating the dosage
`drum 4 as far as possible in a clockwise direction),
`a
`dose can be
`loaded into the injector by
`rotating the
`dosage drum 4
`in an anti-clockwise direction.
`
`rotated in an anti-clockwise
`drum is
`the dosage
`When
`direction,
`the pickup ring 30 must also rotate in an
`anti-clockwise direction by virtue of
`the interlocking
`splines 31 and grooves 41.
`This causes the tags 32,
`33
`on the pickup ring 30 to disengage from the bluff end 21A
`of the adjacent ratchet
`tooth and to move over successive
`ratchet
`teeth 21
`in an anti-clockwise direction whilst
`the ratchet
`ring 20
`remains stationary with respect
`to
`the pickup ring 30. As
`the tags 32,
`33 move over each
`successive ratchet
`tooth,
`a clearly audible “click” is
`heard.
`The spacing of
`the ratchet
`teeth 21 can be such
`that
`each click represents
`a
`specific volume of dose
`being drawn into the injector.
`For example,
`a click may
`be heard for every 18 degrees of anti-ciockwise rotation,
`each click signifying that half
`a unit of
`insulin {or
`other drug) has been loaded.
`
`10
`
`15
`
`20
`
`29
`
`30
`
`35
`
`The
`
`audible
`
`dosage mechanism means
`
`that
`
`a user
`
`can
`
`
`
`9
`
`has
`if he/she
`even
`readily load the correct dosage,
`by
`scale,
`simply
`difficulty in
`reading
`the
`visual
`counting the relevant number of clicks.
`A much slower
`frequency of clicks when rotating the dosage drum in the
`opposite direction helps
`the user distinguish between
`priming
`(clockwise)
`and
`loading
`(anti-clockwise)
`the
`injector.
`It will
`be
`appreciated that
`the
`relative
`spacing of the external and internal ratchet
`teeth,
`the
`slots on the threaded insert
`and the depressed tags on
`the pickup
`ring can
`be varied in differently-sized
`devices,
`for
`example, where
`it may
`be
`required
`to
`calibrate the dosage scale differently.
`
`the
`the Clarity of
`So that no significant degrading of
`“clicks” occurs,
`the component parts need to have good
`resistance to wear. Acetyl may be used where good wear
`and self-lubricating properties are required.
`
`the visual scale in the
`Referring now to Figures 6 and 7,
`injector of the present
`invention has also been improved.
`The dosage drum 4 has a window 6
`therein through which a
`scale indicating the dose can be
`read.
`The window is
`preferably a magnifying lens.
`The rearward part of
`the
`main body 2 which may be visible through the window 6 is
`printed with a number scale on a spiral so that only one
`number at a time is visible through the window, depending
`upon the relative position of
`the main body 2 and the
`dosage drum 4.
`For example,
`the numbers 0-50 may be
`printed on a right hand spiral with a pitch of 3.38mm, as
`illustrated in Figure 7.
`
`feature,
`an alternative or additional
`As
`the dosage
`mechanism may be arranged to emit a verbal
`indication of
`the dose being loaded into the injector.
`For example,
`if
`the number scale shows “20” visible through window 6,
`the
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`
`
`10
`
`word
`
`“twenty”
`
`may
`
`be
`
`emitted
`
`by
`
`voice-synthesis
`
`electronics.
`
`invention thus provides a
`the present
`The
`injector of
`dosage mechanism whereby
`a
` visually-
`much
`improved
`is given a clear indication of
`impaired user
`the size of
`dose being loaded into the injector.
`In this way,
`the
`danger
`of
`injecting an
`incorrect
`dose of
`a drug is
`reduced and the injector is more straightforward to use.
`
`
`
`CLAIMS
`
`11
`
`including an elongate’ main
`injector
`A needleless
`body,
`a dosage drum twistable about
`a
`longitudinal
`axis
`of
`said main
`body
`and
`an
`audible
`dosage
`mechanism, wherein the audible dosage mechanism is
`arranged to emit an audible indication of
`a dose
`being loaded into the injector.
`
`said
`claimed in claim 1 wherein
`as
`injector
`An
`dosage mechanism is arranged to emit audible clicks.
`
`An injector as claimed in claim 1 or claim 2 wherein
`Said audible dosage mechanism comprises
`a
`ratchet
`ring having a plurality of equispaced ratchet
`teeth
`and at least one tag which,
`in use, moves over said
`ratchet teeth so as to generate audible clicks.
`
`injector as claimed in claim 4 wherein said tag
`An
`is fixed with respect
`to said dosage drum so that
`said twisting of
`the dosage drum causes the tag to
`move over the ratchet teeth.
`
`the preceding
`claimed in any of
`as
`injector
`An
`said
`audible
`indication
`is
`only
`Claims wherein
`the dosage
`drum is twisted in an
`generated when
`anti-clockwise direction.
`
`An injector as claimed in claim 5 when dependent on
`claim 3 or claim 4 wherein said ratchet
`teeth and
`said tag are shaped so that, when the tag is moved
`in an anti-clockwise direction with respect
`to one
`of
`said ratchet
`teeth,
`the tag passes over
`said
`ratchet
`tooth and drops onto an adjacent
`ratchet
`tooth,
`thus emitting an audible click.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`
`
`12
`
`said
`in claim 6 wherein
`claimed
`as
`injector
`An
`ratchet
`teeth and said tag are shaped so that, when
`the
`tag is moved
`in a
`clockwise direction with
`respect
`to one of said ratchet
`teeth,
`the tag abuts
`a bluff end of an adjacent ratchet
`tooth,
`can move
`no
`further with respect
`to the ratchet
`teeth and
`hence “picks up” the ratchet ring which continues to
`move together with the tag in a clockwise direction.
`
`said
`claimed in claim 7 wherein
`as
`injector
`An
`ratchet ring further comprises at least one internal
`ratchet
`tooth which, when the ratchet
`ring is moved
`
`in a clockwise direction, periodically passes over a
`detent which is fixed with respect
`to the main body
`of the injector so as to emit an audible click.
`
`the preceding
`in any of
`claimed
`as
`injector
`An
`claims wherein said dosage drum is provided with a
`window through which a
`single number
`representing
`the dose currently loaded into the injector can be
`
`viewed.
`
`10.
`
`li.
`
`in claim 9 wherein said
`claimed
`as
`injector
`An
`window comprises a magnifying lens.
`
`claimed in claim 9
`as
`injector
`An
`wherein
`said number
`is part
`of
`a
`
`claim 10
`ofr
`spiral
`scale
`
`printed on said main body.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`12.
`
`An injector as claimed in any of claims 9-11 further
`comprising means
`for generating a verbal
`indication
`of said number.
`
`35
`
`13.
`
`A needleless
`
`injector
`
`substantially as described
`
`
`
`e
`
`2
`
`ee
`
`one
`
`13
`
`herein with reference to the accompanying drawings.
`
`
`
`wr
`‘ ‘
`Sel
`INVESTOR IN PEOPLE
`
`&a
`
`The %
`2 Patent :
`= Office #
`
`te
`5 +
`“aT Gs
`
`
`
`Application No:
`Claims searched:
`
`GB 0201717.6
`1 to 13
`
`Examiner:
`Date of search:
`
`Mike Henderson
`15 July 2002
`
`Patents Act 1977
`Search Report under Section 17
`
`Databases searched:
`
`UK Cl (Ed.T): ASR (RCJ RCR)
`
`Int Cl (Ed.7): A61M 5/00 5/31
`
`Other:|ONLINE: WPI,EPODOC,JAPIO,TXTUSO,TXTUS1 ,TXTUS2,TXTUS3,TXTEP1 ,
`TXTGBI,TXTWO1
`
` UK Patent Office collections, including GB, EP, WO & USpatent specifications, in:
`
`
`
`
`
`
`
`
`Category)
`
`
`EP 0554996A 1
`
`
`
`
`WO 92/19297A1|(KABI PHARMACIA AB)(Page 9 lines 19 to 33
`
`
`particularly relevant)
`
`
`(HOSHI MITSURUet al) (Abstract particularly
`JP 2001-212237
`
`relevant)
`
`
`Documentsconsidered to be relevant:
`
`Identity of document and relevant passage
`
`Relevant
`to claims
`
`(WIGGINS)(Page 3 lines 7 to 29 particularly
`GB 1225495
`relevant)
`
`(BECTON DICKINSON & CO) (Col 7 lines 21 to
`38 particularly relevant)
`
`
`Documentindicating lack ofnovelty or inventive step
`A Documentindicating technological background and/or state oftheart.
`Y
`Documentindicating lack ofinventive step ifcombined with
`P Document published on or after the declared priority date but before the
`
`
`one or more other documents ofsame category.
`filing date ofthis invention.
`
`
`
`
`Patent documentpublished on orafter, but with priority date earlier than,
`E
`
`
`Memberofthe same patent family
`&
`the filing date ofthis application.
`
`
`An ExecutiveAgencyofthe DepartmentofTrade and Industry
`
`
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