Note: Descriptions are shown in the official language in which they were submitted.
CA 02434201 2003-07-07
WO 02/062488 _ PCT/SE02/00150
Liquid delivery device and method for operating an ejecting device
Technical field
The present invention relates to devices and methods fox ejecting a liquid
strea~ra, in
particular towards an eye, the stream moving from a proximal position towards
a distal posi-
Lion, the device comprising a) a housing, b) a container for the liquid, c) at
least one opening
arranged for ejection of the stream and being in fluid communication with the
container, d) a
pump mechanism operable to deliver at least part of the liquid from the
container through the
I Q opening to form the stream and e) an eyecup with a contact surface
arranged for contact with
the eye ox its facial surroundings. The pump mechanism may include a pump
driver able to
store cocked energy for driving the pump mechanism and at least one activation
mechanism
may be present and operable to initiate the device for the liquid delivery.
Background
I S Devices far ejection of liquid streams may have many utilities. In. the
medical area
typical applications include injection or infusion, treatment of a body
cavities, intrapulmonary
delivery ox treatment of the body surface such as topical treatment. Fox
reasons to be ex-
plained, aspects of the present invention have special utility in
ophthalmology and especially
in liquid treatment of anal eye. Fox convenience and unless otherwise
indicated the invention
20 will be described in terms of this application although-aspects of the
invention has broader
utility.
Devices for delivery of fluids, and in particular liquids, to the eye have
been used
since long for a great variety of purposes. The common eye bath for comfort,
refreshment or
rinsing may comprise a cup of anatomically adapted design fox immersion of the
eye. Deliv-
25 ery of large liquid amounts, usually by spray devices, has also been used
in eye washes for
example in emergency situations. The present invention is mainly concerned
with devices
suitable for administration of relatively small amounts of fluids to the eye
and also devices of
sufficient convenience in handling to facilitate ox encourage frequent use,
also in self
administration situations. A common application is the administration of
medical to the eye.
30 Typically the medical preparation has to be delivered in a fairly well
defined volume to assure
a specified dose to be delivered or absorbed. A large surplus cannot be
allowed due to im~
proper physiological effects from absorbency in non-target tissues or drainage
of excess
amounts through the tear channel into the throat cavity ox the inconveniences
caused by over-
fiow on face and clothes. Also price considerations apply for expensive
medications. As an
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
2
example, the treatment of glaucoma requires frequent daily administrations of
e.g. prostaglan-
dins, beta-blockers or other expensive active ingredients, all having other
then the desired
pressure relieving action when absorbed by other body tissues than the eye.
Moreover, proper
administration of small amounts is complicated by the fact that the active
ingredients cannot
enter the eye but through the limited area of the cornea. Although the device
to be described
herein can be used with any fluid for any purpose, for convenience the
invention will mainly
be described in terms of medical applications.
The circumstances mentioned place severe demands on a device for the general
pur-
poses stated. The necessarily small preparation amount has to be positioned
with great care in
the eye not to invoke the dosing, overflow, side-effect and targeting errors
mentioned. Typi-
cally also secondary steps have to be mastered, such as initiation steps and
control of device
status and preparation condition.
These demands can be met also when using the simplest delivery devices when in
the
hands of a skilled operator who also may initiate medically relevant
corrective measures in
case of accidents and malfunction. Also when using sophisticated devices for
example in a
hospital environment. However, a general treatment trend is to place
administration responsi-
bility on the patients themselves, also in the case of child, elderly and
disabled persons. In
long-term treatment the patient often develop a certain skill but less
frequent administration
schemes also exist, often including situations of emergency or patient
imbalance. Other
unique problems in patient self administration, as compared to assistant
operated administra-
tion, is that less suitable and often strained 'body positions are required
and That apprehended
or experienced pain or discomfort may interfere with the medically desirable
action pattern. In
summary, especially the self administration requires more sophisticated
devices to facilitate
the injection procedure and avoid or reduce risks for mistakes. Patients
dependent on daily or
occasional administrations also have a legitimate need for convenience and
devices discrete
enough to be brought around in daily life. Yet it is desirable that such
sophistication and con-
venience is kept simple and inexpensive to allow for widespread distribution
and inclusion
also in disposable devices.
Prior art devices have only to a limited extent been able to fulfill the
demands stated.
Devices with manually controlled pump mechanisms have been proposed, for
example in WO
98155059 and US 5607410 having features for convenient use or compact
transport form re-
spectively. However, such devices, directed to multiple-dose containers have
no specific
means for self control, e.g. in respect of initiation steps or liquid status.
For some purposes it
is desirable to replace manually operated pump mechanisms with some kind of
automated
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
3
operation, typically involving release of stored energy, e.g. for controlled
initiation, trigger-
ing, forces, speed, reset or sequencing. Also special demand may be posed by
requirements
for high liquid speeds. Medical devices of this kind are for example auto-
injectors, where Iiq
uid injection takes places automatically after triggering, and jet-injectors
where penetration
takes place by use of liquid speed instead of by use of a needle. In eye
treatment fairly rapid
liquid streams have been proposed for the purposes of delivering the liquid
fast enough to
beat the blink reflex and also to enable delivery of very small doses, smaller
than a gravity
delivered drop, by ejection of controlled amount of liquid from a pressurized
chamber throug:
a narrow orifice. Devices of this kind are described in for example in WO
96/00050 for multi~
ple dose containers and in WO 96/06581 and our co-pending application
PCT/SE00/01514 fo
single dose containers. The disclosed proposals of this kind are not optimized
for use as port-
able or handheld devices, neither in respect of convenience features nor in
respect of suitabil-
ity for further automation.
Accordingly there is a continuing need for simple and inexpensive ejection
devices
able to assist the user in the various handling steps involved, preventing or
ameliorating mis-
takes and offering an ergonomic, convenient and non-traumatic product,
especially useful for
patients under self administration. Although the present invention may have a
more general
utility, it will mainly be described against this background.
Summary of invention
A main object of the present invention is to provide an liquid delivery device
meeting
the general demands described herein-above better than hitherto known devices.
A more spe-
cific object is to provide such a device suitable for portable or hand-held
use. Another object
is to provide a device convenient in use and suited for self treatment
situations. Still another
object is to offer a device useful for mechanized, rather than manual,
operation of its liquid
pump mechanism. Yet another purpose is to offer a device having arrangements
for initiation
and/or control steps. A fiuther object is to provide such a device suitable
for automation or
motorization of its functions. Yet another object is to provide a motorized
device providing
energy and/or force economy. Still another object is to provide a device
suitable for high
speed delivery of liquid. Another object is to provide a device compatible
with mufti-dose or
single dose containers. A fiu-ther object is to provide a device suitable for
use with one or sev-
eral replaceable single-dose or mufti-dose containers. Still another object is
to provide devices
as of suitable secondary properties, outside the immediate treatment
situation, such as re-
charging, initiation, control, cleaning, handling and manufacture. Yet another
object is to pro-
vide devices as above suitable for liquid delivery to an eye. A further object
is to provide an
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
4
eye treatment device suitable for convenient and precise delivery, especially
of small liquid
volumes. Further objects are to offer methods for operation of such devices
and/or methods
for delivery corresponding to such devices.
These objects are reached with the characteristic features set forth in the
appended
patent claims.
According to one aspect of the present invention the device is arranged for
liquid de-
livery to an eye and comprises an eyecup arranged to define a given
relationship between the
opening and the eye. By making the eyecup movable between at least two
position, an active
position providing a safety distance between the opening and the eye and a
position closer to
the opening it is e.g. possible to make the device more compact in its not
active state, im-
proving portability, and with increased.space between device and face in
operation, improving
its hand-held characteristics and facilitating self treatment. Making the
variation in relation to
the opening facilitates its precise orientation, of importance for delivery
precision, ~ and its in-
tegration with the housing and pump mechanism, e.g. obviating the need for
long conduits in
between, being more compatible with high pressure delivery. If a sensor or
other arrangement
is used to discriminate between the positions it is possible to adapt the
device functions ac
cordingly, e.g. to generate signals, activating electronics or mechanics,
locking the device etc.
Without sacrifices in other respects it is possible to add further positions
for the eyecup, e.g.
for reset, recharging etc. A movable arrangement is also easily extended into
a fully remov-
able arrangement, e.g. for facilitating cleaning or allowing replacement or
selection between
different eyecup shapes or sizes. The rriobility is compatible with added
functionality where
the movement as such, not only the eyecup position, is critical. For example,
the device may
be active to move the eyecup to the active position when initiation or control
has been suc-
cessfully concluded or the device may be a passive receiver of movement input,
e.g. by using
the movement for arming or cocking mechanisms in the device. It is clear that
the functional-
ity outlined may serve to facilitate automation and motorization capabilities
in the device.
Similar advantages can be obtained in other applications than eye treatment if
application spe-
cific movable parts are made movable in corresponding manners.
According to another aspect of the present invention the device comprises an
activa-
tion mechanism operable to initiate the container or opening for the liquid
delivery and a
driver arranged to transform manual or stored energy both into cocking energy
of a pump
driver for the pump and into energy for operation of the activation mechanism.
Use of a
cocking arrangement for the pump driver means that the user can be relieved
from operating
the pump and can be used to improve the timing, profile and targeting
precision of the ejec-
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
Lion and allows any pump force, container pressure or liquid speed to be
generated. Use of the
same drive mechanism also for initiation facilitates handling in manual
devices and reduces
complexity in automated devices. Initiation steps are common in delivery
devices and may for
example include moving a new single-dose container into the ejection site,
opening of a
5 sealed opening, mixing of preparation precursors, breaking of rupturable
walls or safety parts,
dose setting, de-aeration of container content, arming or release of safety
arrangements etc.
The invention is compatible with any such initiation step or combination of
such steps. The
repertoire of available initiation actions also makes the device compatible
with single-dose or
mufti-dose containers, with single or plural container arrangements and with
fixed or replace-
able such containers. Peak force or energy requirements can be reduced if the
two transfor-
mations are separated in time or sequence. The same applies if two or more
initiation steps are
similarly separated. The arrangement is compatible both with that the driving
mechanism di-
rectly operates the activation mechanism or that the driving mechanism
provides stored en-
ergy to a cocked state for the activation mechanism. The principles outlined
improves use
convenience by reducing the necessary handling steps. They also add to safety
by allowing
control steps to be included and controlled sequencing between steps.
Mechanization and
automation of the device is facilitated by the combined operational actions
and possibilities to
reduce force and energy requirements. For similar reasons the device mechanism
can be made
simpler and less bulky, improving its portability and hand operated
properties.
Further and more specific objects and advantages will be evident from the
detailed de-
scription below.
Definitions
Unless clearly referring to a specific detail, as used herein "system" shall
be under-
stood to refer to the principles of the invention generally, whether
described, claimed, exem-
plified or implemented as one or more devices/arrangements, methods, uses or
combinations
thereof.
In the absence of explicit statements or obvious conditions to the contrary,
as used
herein expressions like "comprising", "including", "having", "with" and
similar terminology
shall not be understood to be exclusively restricted to recited device
elements, composition
compounds/components or method steps but shall be understood to allow for the
presence of
further elements, compounds/components and steps as well. It shall be
understood to cover
any device element in integral, subdivided or aggregate forms and expressions
like "con-
nected", "attached", "arranged", "applied", "between" and similar terminology
shall not be
understood to cover exclusively direct contact between the recited elements
but shall be un-
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
6
derstood to allow for the presence of one or several intervening elements or
structures. The
same applies for similar expressions when used for description of forces and
actions. Simi-
larly, in the absence of explicit statements or obvious conditions to the
contrary, such expres-
sions shall be understood to include composition compounds/components in any
physical or
chemical aggregation or mixture, with possible intervening
compounds/components, or state
of aggregation as well as method steps in any time sequence.
Also as used herein, positional and directional statements for both the
container and
the delivery device, such as "axial", "distal" and "proximal", "front" and
"rear" and "for-
ward" and "rearward", shall be understood with reference to the liquid
delivery direction, with
respect to which a line centered in the container opening and drawn along the
main or average
delivery direction shall be regarded as the system "axis" along which axis the
liquid is deliv-
ered in the forward direction.
Also as used herein the concept "manual" in connection with force or energy
applied
to the controls of the device shall be understood to mean that the operator
applies, directly or
indirectly, the force or energy in a manner controlling the procedure under
consideration. It
shall be understood to include servo arrangements in which force or energy
from another
source than the operator, e.g. stored energy in a spring or gas or supplied
energy, is used in
full or in part in assisting driving of the procedure as long as action of the
operator determines
the proceeding, although servo assistance is mostly not needed or preferred.
In contrast to a
"trigger" action, which may be an on/off action, the manual action bears, at
least partly or
over a limited range, a function relationship to position in the procedure
affected.
Detailed description
General
The device described herein may be used for a variety of purposes within and
beyond
the medical area and for any type of preparations, such as chemicals,
compositions or mix-
tures, in any container and delivered for any purpose. For reasons outlined
the system have
certain special values in connection with medical delivery devices where also
the design con-
straints are more severe than in most other applications. For convenience the
invention will be
described in terms of this application.
Normally the material to be delivered is a fluid and preferably a liquid,
including ma-
terials behaving as liquids such as emulsions or suspensions. These
observations relate to the
final preparation whereas other components, notably solids, may be present
before final
preparation. The nature of container content shall also be understood to
include medical in
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
7
broad terms and to embrace for example natural components and body fluids pre-
filled or
drawn into the container although most commonly the medical is factory
prepared.
The principles of the present invention may be used for delivery devices or
systems in
broad terms. A delivery conduit from the device may be an infusion channel or
any conduct-
s ing arrangements such as a tube or catheter, a needle or cannula or a needle-
less system based
on liquid jet or a drop gun or spray with or without gas propellant. The
container content ma-
terial shall be deliverable by use of a delivery mechanism, also referred to
herein as a pump or
pump mechanism, and any material fulfilling this requirement can be used.
Normally the ma-
terial is a fluid and preferably a liquid, including materials behaving as
liquids such as emul-
sions or suspensions. These observations relates to the final preparation
whereas other com-
ponents, notably solids, may be present before final preparation.
The invention may be applied to delivery devices in stationary or permanent
set-ups.
For reasons explained the invention give special advantages in delivery
devices for ambula-
tory purposes, especially those being autonomous with on-board energy storage,
motor and
processor arrangements and in particular small hand-held devices of truly
portable nature.
The housing
The device housing shall be understood in general terms and mainly represents
the
point of reference, unless otherwise indicated, for movements and also the
point of reference
for forces applied by actuating arrangements performing said movements,
whereat the force is
applied between the housing and the moving or gripped part. Movable parts may
be present in
the pump arrangements or e.g. in parts performing mixing; autopenetration,
needle ejection
and retraction etc. The minimum functional requirement is that the housing
offers a support or
platform for the movable parts and the actuating arrangements providing the
movements and
forces. In the present context such movable parts may be present in the pump
mechanism, its
driver and cocking arrangements as well as in the initiation arrangements and
their activation
mechanisms. As in common practice, however, it is preferred that the housing
forms a con-
tamer at least partly embracing the parts and preferably also to such an
extent that only the
features designed to be controlled or monitored by the operator are externally
exposed. In the
present context such exposed parts may include a manually operated button for
performing or
triggering ejection, a door to a container seat for easy replacement, a
display for messages to
the user etc.
The container
The container part shall be understood in broad sense and may take a variety
of forms
such as any kind of tube, vessel, flexible bag, vial, ampoule, cartridge,
carpoule, syringe body
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
8
etc. Common container materials such as glass or plastic can with preference
be used. The
container may be an integral or composite structure, such as including an
outer casing or any
other multipart construction for closures, fixtures, protection etc., and
whenever used herein
"container" shall be understood to include any auxiliary part present. The
container may be
integral with the housing, e.g. for use in disposable devices, when the
container is refillable
or when the container is part of the pumping system repeatedly drawing the
preparation to be
injected from an external source or channel before each injection stroke. The
container may
also be separate, e.g. for allowing replacement in case of disposable
prefilled containers, for
simple sterilization or scrapping in case of change of content type or
patient. As known per se
more than one container may be present, e.g. in case it is desirable to
perform a mixing before
injection, mixing during injection when drawing a part volume from each
container or in case
of sequential injection of different components.
The container has at least one opening, also referred to as an orifice,
through which
the medication pass during the main delivery operation of the device, either
from the con-
tamer interior to the surrounding for e.g. administration of the medical to
the patient or to the
container in case of aspiration of body fluids or at preparation steps such as
filling, mixing or
dissolution in the container, during which operations the opening need to be
present. It is pos-
sible and even in many situations preferred that certain device operations,
such as initiation,
takes place before communication has been established and the opening
requirement shall
then be considered satisfied by the preparation arrangements for creating the
communication
such as the presence of a removable closure or a pierceable or rupturable part
on the container
itself as in the case of an ampoule or bag or a specially designed part as in
case of penetrable
membranes or septum. All communication may take place through one opening, for
example
both medical passage and pressure equalization in a rigid container or by
delivery from a
container which is flexible or has a movable or deformable part but nothing
prevents that fur
ther openings are provided for similar purposes, which can be identical to the
at least one
opening but which can be entirely different and for example be adapted for
another purpose of
e.g. infusion or syringe type with a movable wall or piston.
The container may be a simple bottle, vial or bag in case the delivery device
is ar-
ranged to withdraw, continuously or intermittently, metered amounts therefrom
for delivery as
defined. Often, and especially in connection with self administration, the
container type is
more elaborate and is commonly in the form of a cartridge, being the container
part of a sy-
ringe type of delivery system, which may be still more elaborate in the case
of multichamber
cartridges. Cartridge type containers shall be fiu-ther described as they
generally require addi-
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
9
tional initiation or control steps for which the principles of the invention
with preference can
be exploited.
A cartridge for the present purposes may generally be said to include a vessel
having
front part and a rear part defining a general cartridge axis, an outlet for
the preparation ar-
ranged at the front part and at least one movable wall arranged at the rear
part, a displacemen
of which wall causes the preparation to be moved towards or expelled through
the outlet. Ves
sel shape and movable wall have to be mutually adapted. The vessel may be
designed most
freely when the wall is a flexible or oversized membrane or diaphragm able to
adapt by
movement or reshaping to vessel internal surfaces, in which case a fluid
cushion or resilient
material may be needed between the wall and piston rod to smooth out applied
pressure. Pref
erably, however, the vessel has a substantially constant internal cross-
section , with a simi-
larly constant vessel axis, between front and rear parts giving a generally
tube-shaped vessel,
and most preferably the cross-section is of the common circular type giving a
substantially
cylindrical vessel. The movable wall is then preferably a substantially shape-
permanent, al-
though possibly elastic, body sealingly adapted to the internal vessel surface
and preferably of
the plunger type having sufficient length to self stabilize against tumbling
during travel along
the vessel. The front part outlet may be of any known design and directed
laterally for best
access in certain applications, frontal but non-coaxial with vessel axis or
most commonly ar-
ranged frontal and coaxial. The outlet may be integral with the vessel or in a
conventional
manner the cartridge front end may be provided with an attachment therefore
and before con-
nection be provided' with a breakable or penetrable sealing. .
Generally the described cartridges need several kinds of initiation actions,
dependent
on a displacement of the movable wall, to reset the device and make possible
repeated and
reproducible dosing meeting high precision demands. In its first movement the
movable wall
may need an extraordinary break-loose force after storage to overcome both
internal reshap
ing resistance and an increased wall friction due to adherence or depletion of
lubricant in
contact points. Also in relation to the weaker regular injection force,
elastic and inelastic de-
formations and tolerances have to be evened out in the movable wall, cartridge
shell, outlet
attachments etc. The preparations themselves may have compressible inclusions
such as gas
vesicles. Deaeration and preejection is needed to remove gas in the vessel
compartment and
fill out spaces for example at the front sealings, outlet attachments and the
interior of the out-
let devices or needles.
Dual or mufti chamber cartridge types are known e.g. for preparations
demanding a
mixing of two or more components or precursors before administration. The
components are
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
kept separated by one or more intermediate walls of different known designs,
which walls
divide the vessel into several chambers, sometimes placed parallel along
cartridge axis but
most commonly in stacked relationship along the axis. Unification of the
components may
take place by breaking, penetrating or opening a valve construction in the
intermediate walls
5 for example by introducing a pin or needle through the cartridge front,
through or at the rear
movable wall or by means at the cartridge exterior (compare e.g. WO 93/02720).
In another
known design the intermediate wall or walls are of the plunger type and flow
communication
between the chambers is accomplished by moving the plunger to a by-pass
section where the
interior wall has one or several enlarged sections or repeated circumferential
grooves and
10 lands in a manner allowing by-flow of rear chamber content into front
chamber at displace-
ment of the rear movable wall (compare e.g. US 4.968.299 or WO 93/20868 and WO
95/11 OS 1 ). The chambers may contain gas, liquid or solids. Generally at
least one liquid is
present. Most commonly in pharmaceutical applications only two chambers are
present and
typically contains one liquid and one solid, the latter being dissolved and
reconstituted during
the mixing operation.
Initiation of the multi-chamber type cartridges requires all the general type
steps de-
scribed, although in aggravated form due to the additional walls and spaces
present. In order
to provide for e~cient mixing generally a mixing space has to be allotted in
addition to the
space occupied by the component volumes. Powdered components in bulk form also
require
the extra space contained in interstices between particles. The mixing step
may produce foam
or gas inclusions requiring space to settle out. Plunger type intermediate
walls generally have
to be displaced at least their own length to reach the non-sealing site in the
by-pass. In total
mufti-chamber type cartridges require long movable wall strokes in the
initiating step, both
for mixing and subsequent deaeration, and benefit in a particular way from the
advantages of
the current invention.
In general the containers exemplified can be used either for single or
multiple doses to
be ejected. In medical applications multiple dose arrangement often involves
the risk of con-
tamination or loss of sterility of the container content after opening and
first use, which may
require preservatives in the preparations. These problems can be avoided with
single dose
containers which are opened in connection with the ejection operation and then
discarded. For
cost reasons the simple and cheap single dose containers have been proposed
having an
opening and at least one wall which is soft or deformable so that the
container content can be
pressurized by squeezing or impacting the deformable part. Various
pressurizing directions
can be used such as perpendicular relative to the opening axis although it is
often preferred to
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
11
use a direction parallel and preferably co-axial with the opening axis in the
forward direction.
Such containers have been proposed for various delivery purposes, e.g. for
needle injection as
exemplified by FR 1538565, for penetrating jet injection as exemplified by US
2642062, US
3419007 and US 5026343 and for eye treatment as exemplified by WO 96/06581 and
our co-
pending application PCT/SE00101514 mentioned in the introduction. Containers
of this kind
can be used for the present purposes and the most preferred design is that
described in said co-
pending application. Such a container can be said to comprise a front wall
having or sur-
rounding a cavity corresponding to the form of an open vessel, an opening in
the front wall
adapted for ejection of the liquid from the container, optionally a sealing
over the opening
adapted for temporary use, and a rear wall closing and sealing the open part
of the front wall
vessel to confine a space for the liquid in the container, the rear wall
running at least partially
perpendicular to the container axis and being displaceable or deformable for
movement to-
wards the opening to pressurize the container liquid. The front wall is
substantially rigid in
relation to the rear wall, that the rear wall before pressurizing the
container is substantially flat
or substantially single-curved and that the rear wall is deformable under
stretching to substan-
tially fill out the container cavity. The pump mechanism for such containers
may include a
ram that press or impact on the soft or deformable wall, to be further
explained below.
Although the above considerations apply to individual containers for single
and dis-
crete use it is preferred to provide for multiple container units or packages.
This can be done
by joining several individual container into multiple structures, e.g. by
flexible joints to allow
' ~ structures that can be bent folded or rolled. Preferably, however, the
multiple container pack-
age is a substantially rigid and self bearing structure, among others giving
advantages in con-
nection with the delivery device. A rigid structure can be obtained by joining
the individual
containers by rigid joints but a preferred way is to utilize the rigidity of
the front wall as men-
tinned by providing an enlarged front wall structure and provide several
cavities in the struc-
tore, among others facilitating manufacture of multiple containers and
allowing a smooth and
non-complicated exterior. By utilizing the feature of making the front and/or
rear surface of
the front wall structure flat or single-curved the attachment of films over
these surfaces is
further simplified, especially if the container surfaces lies in the same
plane since an undi-
vided sheet material can then be attached to several, and preferably all, of
the individual con-
tainers of the structure, e.g. a common foil attached as rear wall to the rear
surface of structure
or a common peel sheet over the container openings at the front surface.
The overall shape of the front wall structure for multiple containers can take
a variety
of forms but essentially flat front wall structures give advantages in
manufacture and delivery
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
12
device design. The shape may for example be rectangular, squaxe or round. The
round "disc"
shape has been found particularly beneficial, among others in connection with
the delivery
device where sequential feeding of the containers into a shoot position can be
made by simple
rotation in a "revolver" type manner, the absence of any particular start
position facilitates
handling and counting arrangements and allows for self centering properties.
Most container types can be arranged in multiple arrangements if desired and
an ini-
tiation step for any such arrangement may include the step of bringing a fresh
container into
an active ejection site of the delivery device or bringing the site to a fresh
container position.
As indicated it is preferred to temporary seal the container opening or
openings before
actual ejection of the liquid in order to maintain a fully sealed container.
The seal should be
broken or removed immediately before use. Although a manually or pressure
breakable rup-
turable seal can be used it is often preferred to use a removable seal in
order to avoid any par-
ticle release from the seal, to have a fully foreseeable dynamic behavior and
allow use of
more reliable thick or strong layers. Generally a seal can be formed integral
with the front
wall, e.g. by molding so as to leave a membrane of material somewhere in the
opening duct.
Preferably, however, a separate peel layer is provided for removal prior to
ejection, and pref
erably attached to the front surface of the front wall. It is preferred to
avoid glue and adhe-
sives and preferably some form of welding is used, as by ultrasonic or heat.
In order to facili-
tate removal and interference with the opening area the sealing can be made to
a limited area
surrounding the opening. In multiple container structures it is preferred to
make the layers
individually removable for each container, e.g. by use of separate films, pre-
cut films orsepa-
rate tongues, e.g. in a star shape for a round disc. For the film material
similar considerations
apply as for the rear wall material, although the film need not be deformable
by stretching and
the demands on impermeability can be slightly reduced in view of the small
opening area. An
initiation step for such containers may be to remove the temporary seal before
ejection.
The opening
The opening design can vary depending on the nature of the liquid stream to be
pro-
duced, e.g. an atomized spray or a concentrated stream to remain coherent or
to break up into
a linear stream of discrete droplets. Also the stream speed may vary from high
penetrating to
low impact surface delivery. Several or multiple openings can be provided,
e.g. to produce a
controlled shower, although for most applications a single opening is
preferred. The opening
geometry can be that of a simple tube, diverging, e.g. for assisting in a
distributed spray, con-
verging, e.g. for assisting in a coherent stream to be formed, or a
combination, such as a ven-
turi type of channel. In high speed applications it is generally preferred to
make the duct part
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
13
of the opening short in order to keep the flow friction low. Although the
opening can be soft,
e.g. in case of infusion tubes, precision advantages can be obtained if the
opening structure is
rigid. The opening in turn can be connected via a tube to the container, e.g.
in case of feeding
tubes, although the opening with preference also can be directly attached to
the container. The
opening will here be described as a termination adapted for delivery of the
preparation to the
target site, e.g. on or in the patient, for which purpose at least the last,
frontmost, part of the
conduit should be suitable for delivery to the site. Depending on the delivery
mechanism used
the front end may not be designed for direct contact with the target site, as
in case of liquid
sprays, where the front end may be an orifice or opening for positioning at a
distance from the
target or on the surface of the target in spite of that the true target is
below the surface. In
other instances the front end is designed for penetrating into the target as
in case of cannulas
or common needles. The channel between the front end and the rear end may be
curved or
bent, as for a flexible infusion tube or in an on-board permanent connection,
although in many
applications it is desirable that the conduit is substantially straight, as
for a needle on a sy-
ringe.
The pump mechanism
The mechanism for delivery of medical through the container opening should
basi-
cally include at least one type of pump mechanism which may have to be
selected for the spe-
cial kind or container and medical used. 'The pump mechanism may include any
kind of pres-
sure source, such as mechanical or electrolytic pressure build-up, in the
container and suitable
valve arrangements for control, which method can be used with virtually any
kind of con
tamer and any kind of product, such as transdermal delivery through liquid
jets, as exempli-
fied by WO 94/2188, or regular tube infusion, as exemplified by WO 88/09187.
Any kind of
container can also be used with pumps based on peristaltic action or
centrifugal action, al-
though also for general use pumps based on controlled positive displacement
are preferred
and especially such pumps based on a separate cylinder and piston action, as
exemplified by
US 5.480.381 for liquid jet or US 4.564.360 for a manually operated needle
based device. The
common syringe type container need a specialized pumping system. Either the
mechanism is
adapted to act on complete syringes, having their own piston rods, by engaging
and axially
displacing said rod, as exemplified by the US 4.978.335, which may be
preferred when it is
desired to accommodate syringes of many different types and sizes, or the
mechanism has a
piston rod acting more or less directly on the piston of a cartridge type
container, as exempli-
fied by WO 95/26211, EP 143.895 or EP 293.958, which can be made smaller and
more
adapted to portable devices. Also dual or multiple chamber cartridges can use
a similar de-
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
14
vices for its various phases, as exemplified by the WO 93102720. Although the
various pump
mechanisms discussed may include mechanical arrangements for affecting the
medical or a
piston the arrangements, such as a piston rod, may be actuated by any known
means, such as
gas pressure, vacuum, hydraulics, springs or manual operation.
The mechanism may preferably include further components. The mechanism may for
example include special arrangements for securing doses delivered, e.g. by
direct metering of
medical delivered , although it is generally preferred to utilize directly or
indirectly the pump
mechanism for this, e.g. by monitoring axial displacement or the rotation of a
piston rod axis
in a manner known per se.
The pump mechanism may also include a manual control, forming the interface be-
tween user and actual pump movement. In case of stored energy the control may
take the form
of a trigger, releasing e.g. a valve or a mechanical lock. In case of manual
operation the con-
trol may take the form of an actuator, directly or via a link system
performing the pump
movement. Preferably a link system incorporates a lever arrangement which may
be used to
reduce the manual force applied, e.g. in case the preparation is too easily
expelled or if a re-
duced stroke length is desired, but preferably is used to amplify the manual
force or increase
the stroke length for the actuator. The manual control may include common
safety details
such as an arming lock or command requirements making the device child proof.
Another known pump mechanism is to pressurize a small cavity of liquid by
rapid and
partial heating of the liquid to vapor formation or by compression by a
piezoelectric element.
Alternatively no pressurizing takes place but liquid adheredto a surface is
thrown by vibra-'
tion of the surface. Such techniques are used for delivery of small drops in
rapid succession
for example in ink jet applications but have also been proposed for treatment
purposes. The
earlier mentioned WO 96/06581 and EP 224352 disclose piezo element and
electrostatic
means for eye treatment, vibration techniques are disclosed in EP 615470, US
5518179 and
US 5838350 and bubble jet technique for eye treatment in WO 94/03135. Such
pump mecha-
nisms can be used for the present purposes, especially for delivery of small
drops as some-
times desirable in eye treatment. In medical applications it is desirable to
use the techniques in
combination with single dose containers for example to better maintain
sterility as has been
explained.
When applying the present invention in connection with a pump driver working
with
cocked energy it is preferred to use the pump mechanisms using relatively high
forces or high
effects since such devices particularly well benefits from the cocking
advantages, for example
the possibility to use a fairly weak motor or manual input to be stored in the
cocking ar-
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
rangement. It is also preferred to use pump mechanisms built on a fairly
simple movement
pattern, such as a rotational or preferably translational movement, for
example when using a
ram for pressurizing the described soft or deformable containers or
piston/cylinder type ar-
rangements as in aspiration/ejection systems or pistons in syringe type
devices.
5 Energy can be stored in the cocking arrangement in different forms such as
electric,
magnetic etc. although it is preferred to use pressure, e.g. in gas or
hydraulic springs, and
most preferably as mechanical energy, preferably mechanical springs.
Similarly the energy input to the driving mechanism can take various forms.
The en
ergy can be manual. Alternatively stored energy in any form can be used, e.g.
the above said
10 forms although the energy preferably is electric, e.g. externally delivered
to the device or
preferably in an on-board battery, to be transfornied by any electromechanical
device such as
a solenoid or preferably an electric motor.
With preference a transmission can be arranged somewhere between the energy
input
and the pumping arrangement, e.g. to modify force, to divide energy also for
initiation steps
15 or to affect sequencing. Typically the transmission involves a gear down
step from lower to
higher force. This transmission may take place after the cocking mechanism
energy storage
but is preferably made before the storage, typically to allow the energy
storage to provide
higher force than the input force. Any known mechanism for the force change
can be used
such as a lever arrangement, a screw and nut arrangement or a gear train
arrangement.
Initiation
As indicated above the various container types may need different initiatiori-
actions.
For example a syringe type container may need an initial piston movement for
various reasons
such as mixing of precursor components. A pistonlcylinder arrangement may need
aspiration
from a vial or feeding tube. A multiple container arrangement may need
movement of a new
container into an active ejection site, herein also referred to as indexing.
Also removal of tem-
porary seals may be needed, herein also referred to as peeling. All possible
initiation steps
shall here not be repeated.
Additional initiation steps can be said to include control steps performed to
avoid mal-
function or to secure that all conditions for successful operation are
present. Such control
steps may be check for the presence of a container in a container seat, check
that the container
is not already used, e.g. empty, check for the presence of a temporary seal
before its removal,
check for correct position of doors, closures, eyecup position etc. Such
control steps can be
used to prevent triggering or issue a warning unless all necessary conditions
are met. As for
the initiation steps mentioned above, some of such control steps can be made
by micro-
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
16
switches or simple mechanical locks or catches but to the extent these
controls need move-
ment of parts requiring significant force or power these steps can be treated
as initiation step.
below.
Although the initiation steps may take place manually or by separate drive
systems,
for reasons outlined there are advantages in using the same drive mechanism
not only for the
cocking step but also for at least one initiation step. Depending on the force
requirement in t1
initiation step a gear down force increase and possibly also a cocking
arrangement for the
initiation may be needed in similar manners as for the pump driver and
possibly the same ar-
rangement can then be used for both purposes. Alternatively, e.g. if the force
or speed re-
quirements are not large, the step can be driven directly without cocking
arrangement and a
gear up or gear down transmission or no transmission can be employed. Often
the two action
need different movement characteristics or are applied to different parts,
requiring at least
some different parts in the driver mechanism, which often is preferred.
Independent of drive mechanism sharing, there are various alternatives for
sequencing
of the actions. The cocking action and the at least one initiation action, for
example cocking
and indexing, may be made may take place simultaneously or at least partly so,
e.g. to save
time between operations. Simultaneous action may either take place due to
movement of the
same part for both purposes, e.g. when having one cocking system for both, but
preferably
different pats of the driver mechanism are involved. In most instances time is
not critical and
it is preferred to perform the actions at least partially in sequence, e.g. to
reduce the force and
power requirement on the drive arrangement, of particular value-in portable
devices. More
than one initiation step may be involved in the device use cycle, such as
indexing, peeling and
control, and it is then preferred to make at least two or more actions to take
place in sequence
to amplify the said advantages.
Some sequencing can be obtained without any active shifting action being
performed
by the mechanism. For example, a single movable member may carry both a
plunger or ram
for ejection and a peeling pin more to the front, securing its arnval before
the plunger be-
comes operative for ejection. Different arrival times can also be obtained
without the parts
being located on the same part or driven by the same parts of the driver
mechanism. Nor-
3 0 mally, however some shift arrangements are needed for sequencing.
Typically the driver sys-
tem need to be disconnected from the cocking arrangement. This can be done by
locking the
cocking arrangement in its cocked state and freeing the mechanism by
disconnection for con-
tinued movement or by reversing motor operation. Similar actions, including
different arrival
times, can be used for sequencing between several initiation action.
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
1~
Operation control
Operation of the device can be said to include the necessary steps for
ejection of the
liquid, initiation steps and controh steps when present and any interaction
thereof such as se-
quencing as described. Control can be made entirely by software means for
highest flexibility,
provided the actuating arrangements present are complete enough to
individually drive the
various parts in their intended movements, such as separate motor means and
solenoid oper-
aced locking and blocking arrangements. To secure operation in correct spatial
relationship
between parts, sensors or micro-switches may also be needed at critical
positions for moving.
Control of such parts can be made by electronics, such as a microprocessor
with appropriate
software.
It is often preferred, however, to provide mechanical arrangements assisting
control
for safest operation and may be necessary if the same motor means are to be
used for different
purposes, such as the above exemplified cocking and initiation steps.
Mechanical shifting
arrangements can easily be placed so as to be triggered by the moving parts at
the critical po-
sitions. Nothing prevents use of combined software and mechanical arrangements
for highest
safety and operation redundancy.
Even if the main device functions are controlled mechanically it may be
beneficial to
include electronics for various secondary purposes, such as for issuing an
alarm or to signal
e.g. a warning or instruction message to the operator, e.g by light, sound,
vibration or display
message. Control of a display may also serve the purpose of informing the user
for example
about timing between administrations, remaining doses in case of multiple-dose
containers or
plural single-dose containers, device status etc. A processor and memory can
also be used to
remember time and doses administered, e.g. for control of compliance with
prescription, and
possibly such data can be downloaded from the device; e.g. from an on-board
EPROM via an
IR-link, for further processing in external equipment.
The various drives described may utilize stored energy in any known form, such
as
electrical, gas pressure or gas releasing, or preferably mechanical, the
latter preferably in the
form of elastic members such as springs. The stored energy can be transmitted
to the force
stated via corresponding conventional transmission arrangements, e.g.
electromechanical,
such as electric motors or solenoids, hydraulic, pneumatic etc. system but
preferably me-
chanical springs are utilized.
Detail regarding use of sensors and signal processing in the device for the
device will
be given below in cormection with description of eye cup mobility since the
general principles
there given is equally applicable for other parts of the device.
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
18
Uses
As indicated, features of the present invention has broad utility and can be
used for
numerous-applications. The invention may have special utility in applications
where it is de-
sirable to replace manually operated pump mechanisms with some kind of
automated opera-
s tion, typically involving release of stored energy, e.g. for controlled
initiation, triggering,
forces, speed, reset or sequencing. The invention may also have special
utility in applications
having requirements for high liquid speeds. Medical devices of this kind are
for example auto-
injectors, where liquid injection takes places automatically after triggering,
and jet-injectors
where penetration takes place by use of liquid speed instead of by use of a
needle. In eye
treatment fairly rapid liquid streams have been proposed for the purposes of
delivering the
liquid fast enough to beat the blink reflex and also to enable delivery of
very small doses,
smaller than a gravity delivered drop, by ejection of controlled amount of
liquid from a pres-
surized chamber through a narrow orifice. The eye treatment application will
be further de-
scribed below.
Eye treatment
A preferred use of the invention is in connection with ophthalmic treatment of
the eye
with medical. The common administration manner is by eye drops or ointments,
however,
having several disadvantages. Both methods generally delivers a substantially
higher amount
than can be absorbed by the eye, not only resulting in dosing uncertainty and
loss of expen-
sive treatment medical but also in potential side-effects when non-absorbed
preparation is
drained away via thewasolacrimal duct, e.g. beta-blocking agents used in- eye
treatment~has
substantial systemic effects. Another problem is that the common
administration methods
tend to induce a blink reflex that may entirely destroy the treatment or of
least introduce a
high degree of uncertainty. Also the common methods do not provide an high
degree of tar-
geting precision, e.g. ability to hit the iris part of the eye being the
penetrable part of the eye
for prostaglandin. The principles used for the present invention solves these
problems, among
others by the possibility to deliver small amounts of liquid, actively ejected
and not deter-
mined by liquid surface tension, by the possibility of delivering the liquid
with sufficient
speed to beat the blink reflex and by the possibility to eject a concentrated
and coherent
stream for precise targeting. Typical parameters for this application will be
given below al-
though the invention shall not be regarded as limited to any such exemplified
parameter. A
typical single dose volume for delivery to the eye can be less than 25
microliter, preferably
less than 15 and most preferably less than 10 microliter. Generally the volume
is at least 1,
preferably at least 2 and most preferably at least 3 microliter. Since it is
desirable that each
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
19
container contains a single unit dose, these figures also relate to the liquid
volmne charged
and contained in the containers, possibly allowing for some overfilling to
compensate for nor
ejectable amounts, such as liquid remaining as wetting film or in the
container opening duct,
e.g. 25% but preferably no more than 10% overfilling. In addition to the
liquid the container
may contain other material, notably gas such as air or a purging gas such as
nitrogen or noble
gases, e.g. to facilitate manufacture, assist in atomizing or act as pressure
buffer, although in
many instances little or no gas need to be present. A suitable speed for the
stream of drops or
jet ejected should be a balance between on one hand enough linear momentum to
traverse an
air gap between opening and target, without gravity assistance, and to travel
fast enough not
be obstructed by blinking and on the other hand not so fast as to cause
inconvenient sensible
impact on the eye. The ideal speed is to some extent dependent on the drop
size used but as a
general rule the drops should be able to traverse at least 1 cm, preferably at
least 3 and most
preferably at least 5 cm through air by own momentum, incorporating reasonable
distances
between opening and target. A suitable lower speed limit when leaving the
opening is 1, m/s,
preferably at least 5 m/s and most preferably at least 10 mls. Generally the
speed is lower than
200 m/s and preferably lower than 100 m/s. A suitable drop size so defined
should be suffi-
cient not to be retarded too quickly and not to be easily redirected, e.g. to
be inhaled, and
preferably has a minimum diameter of 20 micron, preferably not less than 50
micron and most
preferably at least 100 microns. Normally the size is less than 2000 micron
and preferably less
than 1500 micron. The stream may take the form of a shower or spray of
atomized liquid
w ~dropiets but preferably the stream is narrow and fairly coherent although-
even such a stream
tend to break up into individual droplets after a certain time of distance.
The above given val-
ues are intended to relate to spherical droplets and for multiple droplets to
the weight average
of particle diameters. A coherent stream tend to break up into droplets of a
diameter of
roughly double the diameter of the stream. Accordingly suitable opening
diameters for the
containers are about half the above given drop diameters or roughly between 10
and 1000
microns, preferably between 20 and 800 microns. The above considerations are
fairly inde-
pendent of liquid viscosity and tend to apply both for solutions and
ointments.
The eye cup
Many of the advantages provided by the present invention are exploitable also
without
an eye cup part of the device, provided the operator take responsibility for
device orientation
and stabilization. It is preferred, however, that an eye cup part is included
to relieve the op-
erator from these responsibilities. A suitable eye cup part comprises at least
a rim and a cav-
ity.
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
The purpose of the rim is to give a contact between device and face for and
preferably
also a self centering of the device in the intended position relative the eye.
The contact can be
against any part of the face such as the forehead, nose and cheek but a
generally better cen-
tering is obtained if the rim make contact with the eye socket. The "rim"
shall be understood
5 in broad sense as the point or points of contact and need not be shaped as
an edge or other
elongated part but shall provide at least one point of contact preferably two,
three or several
points distributed in two dimensions for best centering. The points can with
preference be
shaped as one or several continuous edges and most preferably as a continuous
loop. For pur-
poses of description it is assumed that a line can be drawn so as to connect
the contact points
10 into a "contact curve", representing also theoretical face contact points
not being actually
contacted by the rim and in case of a closed continuous rim the contact curve
and rim edge are
assumed to coincide. A plane drawn to contain the contact curve forms a
theoretical "contact
plane". A line drawn normal to the plane forms a "contact axis" and a "contact
direction"
along the axis from the device towards the eye or, expressed in another way,
from the cavity
15 towards the rim. The contact axis and contact direction shall be regarded
"symmetrical" if, in
device related terms, they are centered within the contact curve or if, in
patient related terms,
they are radial to the eye ball. Suitable rim forms are known in the art and
are not very critical
to the invention. It is preferred to use a rim shape with left/right symmetry
to make it equally
usable for both eyes with a similar grip. A rim having a contact curve
substantially in the form
20 of an ellipse, adapted in size and shape to the eye socket, can for example
be used. The con-
tact plane through such a generally ellipse shaped form can be flat although
frequently
slightly curved along an axis parallel with the short axis of the ellipse. The
rim can in a
known manner with preference have eyelid retractor protrusions, preferably in
the contact
direction, for specific contact with at least the lower, but preferably also
the upper, eyelid for
the purpose of displacing and retaining the eyelids. Constructively the rim
can have a soft
edge for comfort and preferably a material of high friction, at least on any
eyelid retractor
part. The rim may be integral with the cavity part but is preferably a
separate part attached,
glued or fused to the cavity part for free material or color contrast
selection.
The cavity serves the purpose of providing space within the contact curve
boundaries
for the protruding eye ball and also to secure a safety distance to the eye
ball for any part in
front of it, especially the orifice to be further explained. Accordingly the
cavity shall be un-
derstood in broad terms for any construction meeting these objects. The cavity
can be a true
cup, as in known eye baths, but has no function as such and it is preferred
that it has a more
open design, e.g. to allow access to the orifice for opening and closing, to
avoid preparation
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
21
accumulation and facilitate cleaning, to allow an assistant operator to
visually monitor orifice
orientation and delivery, to facilitate manufacture etc. A minimum requirement
is that the
cavity construction provide support and attachment for the rim, e.g. a single
arm or bar ex-
tending away from the rim in a direction opposite the contact direction,
although two or sev-
eral arms can be used for example in a cage-like design. With further details
below, the eye
cup shall be arranged at the orifice of the container in a manner allowing
delivery of fluid to
the eye and in particular within the contact curve of the rim. The
relationship may depend on
the delivery principle used, with special freedom at drop delivery, but
generally it is preferred
that the orifice is positioned behind, when seen opposite the contact
direction, the contact
curve and with a projection along the contact direction within said curve. The
orifice can with
preference point into or be arranged within the cavity, preferably with at
least a fluid delivery
direction component parallel with the contact direction. It is preferred that
a certain safety
distance is maintained between the orifice apex and the contact plane, to
prevent contact with
the eye ball for any foreseeable individual anatomy and to prevent~patient
fear for such con-
tact, e.g. a distance of at least 5 mm, preferably at least 8 mm and most
preferably at least 10
mm. The abovesaid support and attachment of the rim via the cavity
construction can be made
to the container or its orifice but it is preferred to attach the rim to the
hand grip part, e.g. for
allowing unobstructed replacement or the container.
The eyecup may include auxiliary features such as details assisting proper use
and tar-
geting, e.g. some fixation point for the eye, for example a mirror, a light
etc.
~. .. - . Eye cup mobility
When using an eyecup it is preferred to arrange it movable with respect to the
hous-
ing. The eyecup can preferably be movable between at least two position, an
active position
providing the described safety distance between the opening and the eye and a
position closer
to the housing, e.g. to make the device more compact in its not active state.
The container
opening can be fixed in relation to the eyecup, e.g. to move together with the
eyecup, but in
most instances it is preferred that the eyecup moves relative the opening,
which is then ar-
ranged fixed with respect to the housing, certainly with maintained options
for container re-
placement or movement of plural containers to and from an active site. The
eyecup can be
movable info more positions, e.g. farther away from the housing or opening
than in the active
position, e.g. to improve access to the eyecup or to housing parts etc. With
preference the
eyecup can be entirely removable from the housing, e.g. for cleaning purposes.
The eyecup
mobility can be in any direction as long as the above requirements axe
satisfied, e.g. so that
the eyecup contact direction has at least a movement component along the
opening axis. The
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
22
movement can be purely translational or may have a rotational component, the
latter prefera-
bly being obtained by a hinged arrangement for the eyecup or its attachments.
It is preferred
that at least some of the positions are well defined, preferably at least the
active position and
preferably also the rest position, e.g. by friction, snap lock, ball locks or
even a full releasable
locking.
It is preferred that a sensor or other arrangement is used to discriminate
between the
positions and preferably so that signal is issued on which the device may use
for action. The
signal can be able to distinguish between all possible positions in a
continuous way although
it is often preferred the sensor issues discrete signals for example in at
least one, preferably at
least two and most preferably at least three positions. The signal can be of
any kind as long as
it is possible to transform it into action, preferably an electromagnetic or
mechanical signal.
The signal received from the sensor can be in the form of, or transformed
into, an
electromagnetic signal representative for the position as described. The
electromagnetic signal
may be based on electromagnetic radiation, such as an optical signal, but is
preferably an
electric signal. Many suitable components for use as sensors are designed to
give such a sig-
nal output but may otherwise be inserted in a circuit securing such an output.
Any inherent,
integral or separate arrangements of this kind can be regarded as a converter
for sensor output
into the electromagnetic signal. For example, one or more micro-switches may
be arranged
along the eyecup translational path or along a rotational path, e.g. a cam
surface arranged at a
hinge axis.
Similarly the signal received from the sensor can be in the form of, or
transformed-
into, a mechanical signal representative for the position, e.g. a part
connected to the movable
eyecup and in some way moving together with it. Any known transmission
arrangements can
be used as converter for the signal into the desired movement action with
similar considera-
tions as for the electromagnetic signals. Nothing prevents that an
electromagnetic signal is
transformed into a mechanical signal or vice versa or are mixed in the signal
chain.
The signal so received or converted can in general terms be said to be
processed in for
example a processor or transmission to deliver a control signal. The control
signal in turn is
used to control a functional or operational component of the device. The
operational compo-
nents can be of any kind although some typical examples will be given below.
Also the con-
trol signal can be of any nature, such as mechanical, optical etc., dependig
on its further use.
The control signal may be used to issue a message to the user, e.g. to warn or
alert the
user of an improper condition before the device is activated for delivery. The
message may be
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
23
a sound, a tactically sensible signal such a vibration, a visual signal in the
form of a warning
lamp or a more complicated message on a display etc. or any combination of
such messages.
It is preferred that the control signal is used to control the basic device
functions over
the actions taken by the operator. The control signal may be used to enable or
disable the de-
vice respectively, dependent on the proper eyecup condition. The
enabling/disabling may tak
place by a mechanical link or by an electromechanical link, such as a relay
device blocking a
mechanical function e.g. a piston rod or pump mechanism. Better is to use this
function in
connection with devices having at least some automation means for driving the
device, such
as an electric motor, the operation of which may be determined by the control
signal. Still
better is if the device further includes processor means for control of the
motor means, e.g. in
order to secure proper container control, initiation, sequencing of actions,
dosing, feedback of
administration data etc. in which case the electromagnetic signal can be fed
to the processor
for further flexibility, e.g. allowing the processor to issue a motor
activation control signal
only when the eyecup condition is fulfilled or only when the initiation steps
have been prop-
1 S erly concluded or proper condition has been positively verified in a self
control program. An
existing processor unit may here act as the processor between the
electromechanical signal
and the control signal.
The control signal may further be used to actually trigger the device, i.e. as
soon as the
sensor signals the predetermined position condition an automatic function
starts. As for the
enabling/disabling condition just described this triggering function can be
used for purely
mechanical driving means via an electromagnetic release mechanism, better
together with
electric motor means an most preferably with processor controlled automation
in the device.
It is preferred that the device is arranged to take at least one in the
initiation and ejec
tion sequence. A preferred arrangement is to arrange so that the device can
only be triggered
when the eyecup is in the active position, or active state. The rest position,
or rest state, can
for example be used to disable triggering, put the device in a low energy
consumption state or
initiate a new cycle of initiation steps. A third position can be used to
signal other device
states than rest state or active state, for example a reset state or a change
of container state and
may include a step giving access to the container seat. It is also preferred
that movement as
such, not only the eyecup position, is critical and used for action. For
example, the device
may be active to move the eyecup to the active position when initiation or
control has been
successfully concluded or the device may be a passive receiver of movement
input, e.g. by
using the movement for arming or cocking mechanisms in the device.
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
24
It is clear that the above general sensor principles can be used also in
devices for other
purposes than the eye treatment. The operations actually enabled or triggered
can then be of
various nature. Preferably at least the ejection is affected, in multidose
devices perhaps in-
cluding mechanical but preferably electric control of the dose delivered. In
jet injectors sen-
sors can be used for contact triggering. In autoinjector type devices the
autopenetration step
may also be affected, preferably so that the sequence of autopenetration and
autoinjection is
controlled, possibly with a final needle retraction step. Autoinjectors are
known which either
deliver preparation also during the penetration phase or enable the injection
first at completed
penetration and the invention is compatible with both modes of operation. In
case of mul-
tichamber cartridges with overflow or by-pass arrangements, which are known as
such, the
injection procedure may incorporate injection of different preparations in
sequence, such as an
anesthetic followed by an active ingredient or an active component followed by
an rinsing
component.
Device example
Below some considerations will be given for a use example in which a device is
ar-
ranged to utilize the container types described above with reference to our co-
pending appli-
cation PCT/SE00/01514 and especially the described multiple container
arrangement in the
general revolver type disc layout.
A delivery or dispenser device for such a purpose can generally be said to
comprise a
housing with a seat for the container or container structure, a ram movable in
relation to the
housing in a direction substantially axial to the container when iri the seat,
ari actuator ar=
rangement operative to drive the ram.
The housing should contain a seat for a container or several containers, the
minimum
requirements on which is that at least the container to be emptied is kept
fixed in relation to
the rain, preferably so that the container axis and the movement axis for the
ram are parallel
and most preferably coaxial with respect to the ram part to hit the container
rear wall. Prefera-
bly the seat should be able to accommodate containers with the characteristics
described
herein. The seat preferably supports the container against forward forces from
the ram and
preferably also against some rearward and lateral forces. The seat preferably
allows the entire
rear wall surface over the cavity to be exposed to the ram and should also
expose at least the
opening or openings on the front side of the container not to obstruct the
liquid stream, al-
though the rigidity of the present containers do not require any heavy
support. Preferably the
seat is also designed to allow easy exchange of discrete containers, or
sequential movement of~
the individual containers of a multi-container structure, into the active
position of the seat, e.g.
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
by having a track in which the structure can be moved in one or two
dimensions. In the pre-
ferred embodiment of containers placed in a circle, preferably on a disc
shaped structure, it is
suitable to rotate the disc around a central disc axis to bring the containers
into alignment with
the active position, in a revolver type manner. Such indexing maneuvers may
take place as an
5 initiation step for example before or after cocking a spring for the ram
ejection action. For
single and in particular multiple container arrangements it is desirable that
guiding arrange-
ments are provided to secure good alignment with the ram axis in order to
reach high delivery
precision intended, e.g. structures provided in connection with each container
on the package
for cooperation with at least one corresponding locking structure on the
housing, seat or pref
10 erably ram, arranged for interlocking at proper alignment. Locking
therebetween can with
preference be associated with a signal to assist stop in correct position,
e.g. tactile or audible
signal in manual operation or a mechanical or electronically detectable signal
in automatic
operation. Additionally it is preferred to include a counting arrangement,
again manual or
automatic, mechanical or electronical, designed to keep track on the number of
containers
15 used or remaining and warning for or preventing reuse of already emptied
containers.
The ram may include a ram head and piston arrangement for moving the ram head
along the movement axis. Although it is possible to design the ram head non-
congruent with
the container cavity, e.g. for use with different cavity shapes or when
relying on rear wall
stretch properties for emptying, it is preferred to design it for complete
fill-out of the cavity.
20 This can be done with a soft and adaptable ram head, e.g. for the purposes
of being compati-
ble with different cavity forms, to increase operation range or to obtain a
certain emptying
pattern, preferably to squeeze out the liquid from the peripheral cavity parts
towards the cen-
tral, axial, parts which can be done for example by malting the soft ram head
slightly shal-
lower in shape than the shape of the cavity vessel form. For a single cavity
form it is, how-
25 ever, preferred to make the ram head front surface substantially identical
with the inner cavity
surface or, expressed in another way, the rear surface of the front wall in
the container space.
The ram head can be surrounded by a support, e.g. a tube structure in which
the ram head
travels, which is preferably also abutted around the cavity to seal the space
between ram head
and cavity at least during the rear wall collapse movement, e.g. to allow high
pressures or
reduce leakage risks. The piston part of the ram is generally not critical to
the dynamics of the
ejection but rather far propulsion and will be described in connection with
the actuator sys
tem.
The ram can be propelled by use of a variety of mechanisms and energy sources.
The
mechanism can be operated directly with manual energy, in which case, however,
it is pre-
CA 02434201 2003-07-07
WO 02/062488 ~' PCT/SE02/00150
26
ferred to provide an leverage or gear exchange to amplify or transform force
or speed, pref
erably towards lower speed and higher force. In order to have controlled and
consistent result;
it is generally prefeiTed to have automatic function in the sense that after
operator triggering
the propulsion takes place automatically, and preferably irreversibly, by use
of stored energy.
The energy may be stored in any way, e.g. in a mechanical spring, a gas spring
or gas gen-
erator, as electrical energy or a combination thereof. The energy may be
transmitted to the
ram by suitable motor or transmission arrangements, e.g. electric motor or
solenoid type mo-
tor for electrical energy, a piston and cylinder arrangement for gas springs
or gas generators
and rotation axis or plunger for coiled and helical springs respectively. It
is generally pre-
ferred to include a transmission between the motor means and the ram proper,
among other to
provide a force amplification, e.g. by use of a gear wheel or a cam surface
type of transmis-
sion. It is preferred that at least the ram head, and preferably parts of the
ram piston, are pre-
vented from rotation during forward movement, which can be secured by any
known guiding
structures, such as a non rotation symmetric part cooperation with a
complementary part, the
parts being positioned on ram and housing respectively. A preferred
transmission component
for propulsion of the ram is a screw and nut arrangement, one of which is
positioned on the
ram and the other on the motor side of the transmission. The necessary speed,
force and
movement characteristics for the ram depends on a number of conditions, such
as the nature
of the container parts and opening, the particular application implementation,
e.g. surface or
penetrative delivery, the viscosity of the preparation, e.g. aqueous solutions
or ointments, etc.
and general statements cannot be given. However, the energy sources, motor
means and
transmissions exemplified can be adapted to each need. It has also been found
beneficial to
include a damper, e.g. a dash pot, a linear damper, a flow valve, a magnetic
damper etc., to
control speed with maintained stable force. In most applications it is
desirable to have a rapid
rise and fall of pressure, generally requiring a stable and non-retarded speed
of the ram, which
is facilitated e.g. by a damper or high inertia in ram and transmission.
It is also preferred to include in the device arrangements to facilitate
breakage or re-
moval of the temporary seal over the openings as described. Although it is
possible to break a
seal by the pressure itself generated when collapsing the rear wall it is
preferred to use an ac-
five step to break the seal. This can be done by having a de-sealing tool
arranged in connec-
tion with the housing, e.g. a penetrating tool for a rupturable sealing or a
wedging or drawing
arrangement for removal of peelable sealing films. Such arrangements can be
located at or
close to the seat, e.g. to allow late action, or remote, e.g. if the seat area
is crowded. The de-
sealing tool can be operated manually or automatically or compulsory, e.g. as
a part of the
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
27
movement of container into the seat site. It has been found beneficial,
however, to position the
de-sealing tool on the rear side of the container for movement from rear to
front, which allows
the de-sealing tool to attack the film in the best manner possible, i.e. on
the film rear side to
lift it from the front wall front surface. It also allows the de-sealing tool
and mechanism to be
arranged more conveniently within the housing and to the rear of the container
for less inter-
ference with the ejection area and ejection target but most preferably
The tool can be arranged on or in connection with the ram in such a manner
that it
moves together with the ram, utilizing the same movement mechanism and
facilitating a re-
moval immediately before ejection and as an unavoidable part of the ejection
procedure. For
reasons earlier outlined the tool can preferably have a movement mechanism of
its own. Pref
erably the de-sealing tool passes though an opening in the front wall
structure, and possibly
also through the rear wall, at a location not occupied by the container cavity
but covered by
the sealing film. With preference the dimensions of such an opening and the de-
sealing tool
can be mutually adapted so as to act as a guiding arrangement, as described,
for final align-
ment of ram and cavity before activation. In operation the tool first lifts
the film from the
container opening and the ram head then hits the container rear wall. It is
possible to perform
these two steps in a single continuous movement for the ram, e.g. for simplest
operation and
latest possible de-sealing, or in a two-step operation, possibly requiring two
triggering actions
from the user, e.g. in order to enable the user to verify that the film has
been properly re-
moved. It might also be of interest to use different movements characteristics
for the two
steps, e.g. a slow movement for the peel not to cause tearing or rupture-and
a~fast action for
ejection, which might require some shift arrangement, e.g. a gear shift, de-
coupling of bxake
or damper etc. The general container design principles of the present
invention strongly am-
plifies the above described advantages, among other by having a rigidity
permittig front wall
use for guiding purposes and allowing areas outside the cavity part to be
utilized without in-
stability problems.
A device as exemplified can be adapted for different uses. Depending on each
appli-
cation it may be beneficial to equip the device with arrangements assisting
targeting and posi-
tioning. For example, when used for shooting liquid to the eye the device can
have an eyecup
as earlier described. Penetrating applications may require small distance or
direct contact be-
tween opening and target surface, and possibly an arrangement for device
triggering at a cer-
tain contact pressure of an end piece towards the target site. Larger surface
treatment may
require an end piece defining both an angle and a distance
Method
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
28
The above description has been made with reference both to structural and
operational
features, directly or indirectly, or follows from the descriptions made of
structures, functions
and objects. The invention shall be regarded to incorporate and embrace both
the device and
method aspects and characteristics described. The methodological aspects are
not separately
repeated. Method aspects will also be exemplified below in connection with the
drawings. In
other aspects the ejector of the invention may be used conventionally or as
described in prior
art.
Summary of drawings
Figure 1 A shows in exploded view and Figures 1 B to 1 G the device in cross-
section
during five operational phases of an embodiment driven by batteries and an
electric motor and
utilizing a disc having a plurality of single-dose containers designed for
being pressurized by
a ram. Figure 1 H shows in greater detail the components of the main lever.
Figures 2A to 2C show schematically in an open view and in two cross-sections
re-
spectively an alternative embodiment of an entirely mechanical device which is
arranged to be
cocked by manual energy.
Description of drawings
Figures 1 A to 1 H depict an a device in which an on-board electric motor is
used to
cock a pump mechanism pump driver during retraction of a peel pin, with final
indexing of its
disc container, followed by forward movement of the peel pin for sensing and
final removal
or a temporary seal in the form of a foil over the container openings.
Figure 1 A shows an-exploded view of the device components. The device 100 can
be
said to comprise a housing 110, having an upper body 111, a lower body 112,
and externally
accessible trigger 113. The housing also comprises a door 114, which can be
opened, when
the eyecup is a remote position, for insertion or replacement of disc 116 with
a plurality of
containers 117 with openings 118 and peel holes 119. A movable eyecup 120
comprises a rim
122 attached to arms 124 which is connected in its other end to hinge axis
pins 123 supported
in bearings 128 and 128', the latter having a cam part (not shown) moving with
the eyecup,
which cam part affects internally arranged sensors to be described. The
housing further com-
prises a window 124 over a display and a battery closure 125.
The housing interior has a chassis upper part 126 and a chassis lower part 127
carry-
ing the device mechanism.,Said mechanism can be said to include a driving
mechanism, gen-
erally designated 130, a transmission 140, a pump mechanism 150 with
arrangement for
stored cocking energy, a peel mechanism 160, an indexing mechanism 170 and a
control sys-
tem 180, including a board 181 for electronics.
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
29
The driving mechanism 130 can be said to include the motor 131 with batteries
(not
shown) having a rotating shaft with a front encoder 132 for counting of motor
revolutions anc
an external screw-thread 133 for cooperation with the upstream gear wheel in
the transmissio
chain. The motor and detectors for motor revolutions are attached to the
electric board 181.
The transmission 140 can be said to comprise a set of gear wheels in a gear
train ar-
ranged to gear down motor speed and increase force in adaptation to each
function. A peel
wheel 142 is arranged to drive the peel mechanism, intermediate wheels 143 and
144 are part;
of the gear trains without any further function and a cocking wheel 146 is
arranged to drive
the cocking mechanism for the pump mechanism. See also Figure 1H for details.
The pump mechanism 150 can be said to include a lever
15?~w~,'_ch_canxotate_a~und~
a lever axis 153 allowing its end at the eyecup end of the housing to move up
and down. At
the other end of the lever is a damper attachment 154. The damper attachment
is connected to
a piston part of a damper 157, the cylinder part of which is arranged
stationary. In this ar-
rangement the piston is moved against vacuum and bleeding of air into the
cylinder, for re-
tarding the speed of the ram impact. The pump mechanism includes a ram 158
rotationally
connected to the lever at 159 and guided in the chassis, allowing the ram to
attack the con-
tainer deformable rear wall in a substantially straight movement. Downwards
movement,
away from the eyecup in the shown position, of the lever 152 is used to cock
springs 156 in
the pump mechanism. The cock springs are arranged to throw the ram upon
release towards
the container 117 to eject liquid through the openings 118. As best seen in
Figure 1H, the
lever has a nut 151., with internal screw-threads (not shown), for cooperation
with corre-
sponding threads associated with a screw, with external threads, rotating
together with the
cocking wheel 146 in the transmission. The nut is attached to the lever,
allowing movement of
the lever up and down depending on motor direction. The nut is attached to the
lever to catch
it only in the cocking direction, not in the release direction. A spring
biased L-shaped ram
lock 155 is arranged to go under the lever 152, when in the cocked position,
to keep it there
until release. After motor reversal the nut may then move free from the lever
in the release
direction until it hits the lower leg in the L-shape, which will release the
ram lock and throw
the ram, and this will happen when the peel pin 162 has reached about its most
forward posi-
tion and accordingly completed peeling.
The peel mechanism can be said to include the peel pin 162, which is keyed at
164 to
the chassis to prevent its rotation, and has internal threads 166 for
cooperation with external
threads on peel wheel 142 to allow its movement up or down by the motor. It is
clear that in
this embodiment the motor and transmission drives the peel pin directly and
not by cocking
CA 02434201 2003-07-07
WO 02/062488 3o PCT/SE02/00150
springs or similar energy storage. At the end of the forward peeling movement
the pump
mechanism is activated to throw the ram by release of the ram lock 155 in the
manner de-
scribed above. At the rear side of the peel wheel 142 is a force sensitive
sensor 168 arranged
to switch at a certain counter-force from the resistance force the peel pin
has to overcome
when the temporary seal foil is torn away, which allows the control system to
verify its pres-
ence.
The indexing mechanism 170 comprises an index wheel 172, for cooperation with
the
correspondingly shaped container disc hub, with teeth corresponding to an
equal number of
containers on the disc. The index wheel has certain mobility and is spring
loaded to facilitate
connection to the disc. At the other end of the index wheel are toothed inner
catch wheel 173
and outer catch wheel 174. An increment arrangement is driven by the peel pin
I 62 keys 164,
which on rearward movement affects a tapered surface 176 of an axial lever
175, which in
turn affects a radial lever 177, which is in hook contact with inner catch
wheel 173, to turn the
index wheel one tooth. A counter lever 178 is in spring biased hook contact
with outer catch
wheel to prevent the index wheel from rotating in the opposite direction. The
indexing corre-
spond to one tooth after ejection in each operation cycle and lines up a fresh
container with
the ram. This is an incremental action initiated when the peel pin during its
rearward move-
merit arrives at a remote position relative the eyecup part of the device, in
which position the
pin has been withdrawn from disc peel hole to enable its rotation. This action
is also sensed
by a counter sensor (not shown), which is used by the processor on the board
181 to decre-
merit the displayed number of remaining doses figure on the display. The
processor is also
arranged prevent triggering after all doses of the disc being ejected or if a
defect container has
been detected, then moving the peel pin to its rearmost position, which
triggers opening of the
door for disc replacement.
As indicated most electronic components are positioned on the electronic board
181.
In addition to the features mentioned the control system 180 can be said to
include the display
182, also connected to the board, and a door locker 183 with arms 184
affecting a door sensor
188 depending on the door position Further, sensors 185 and 186 cooperates
with the men-
tinned cam surfaces in bearing 128' for detection of eyecup position. A switch
I89 is arranged
on the chassis upper part 126 to be affected by the trigger 113. A processor
187 is arranged
for operation of the device.
Figure 1 B to 1 F show the various phases of the device operation. Figure I B
corre-
sponds to a Standby position, immediately before an ejection cycle. The peel
pin 162 is in an
intermediate position immediately to the rear of the foil to be removed. It
should be noted that
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
31
the cock springs 156 are already in a cocked state, which cocking has taken
place earlier dur-
ing a rearward movement of the peel pin, and the damper 157 is in its initial
position. In the
Touch foil position shown in Figure 1 C the trigger has been activated and the
motor has
moved the peel pin a small distance forwards to the point where it has
penetrated the peel hole
119 in the disc and touches on the foil to verify its presence via sensor 168.
In the Peel off
position of Figure 1D the peel pin 162 has completed its forward movement and
removed the
foil. In the Injection position of Figure 1E, at the forward extreme for the
peel pin, the ram
lock 155 has been released, which has triggered the ram 158, which has
completed the ejec-
tion in the position shown. The lever 152 has moved up to the right in the
Figure, under influ-
ence of the cock springs 156, and down to the left under withdrawal of the
damper 157 piston.
In the Start index position of Figure 1F the device has been re-cocked during
return move-
ment of the peel pin, by again reversing the motor and the peel pin in a more
rearward posi-
tion than in Figure 1B in which indexing of the disc is initiated during
further rearward
movement of the peel pin. During the late part of this rearward movement for
the peel pin
indexing of the disc will be completed. By again reversing the motor the peel
pin can be
moved forwards to the Standby position shown in Figure 1B. In this position
the device is
ready for a new ejection cycle if the trigger 113 is pressed and if the eyecup
120 is in the
shov~m active position. Alternatively, as shown in the Open cover position of
Figure 1 G, the
processor may move the peel pin to a still more rearward position than in the
Start index po-
sition shown in Figure 1F, which will release the mechanical lock for the door
114 in order to
~~ allow disc replacement; which will also require that the eyecup~is sWUrig
to a remote position
about 180 degrees from the position shown. This will happen if all containers
of the disc have
been used or if a fault has been detected.
Use of the device will be described from a start position in which the device
is in the
Standby position as shown in Figure 1B. If the eyecup is in the rest position
(not shown) it
need to be moved to the shown active position to activate the device. The
display may show
an alert signal, e.g. by flashing. The eyecup is placed against the eye and
the trigger activated,
which is only possible with the eyecup in the active position, and this will
initiate a full se-
quence of peeling, ejection and indexing in a compulsory manner by the actions
described
above until the device is again in the state of Figure 1B. Alternatively the
trigger activation
will only make the device proceed to full peeling of the foil as illustrated
in Figure 1D. Then a
new trigger action will be needed to complete ejection as shown in Figure 1E
and automati-
cally proceed to full completion as illustrated in Figure 1B or to the Open
cover position of
Figure 1 G. The second triggering shall be made within a certain time frame
from the first
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
32
triggering, otherwise the processor will automatically proceed to end and the
dose is lost. This
in order to not risk container contamination after opening. When all doses
have been con-
sumed the processor will activate the motor to drive the peel pin to its
rearmost position as
shovm in Figure 1 G for disc replacement. After detection of a fresh disc the
processor will
move the peel pin to the Standby position shown in Figure 1B and the doses
counter will be
reset.
Figures 2A to 2C depict an overview of a modified device as compared to that
of Fig-
ure 1 and the following description will mainly focus on the differences. The
Figure 2 device
is entirely mechanical and is arranged to be operated by manual energy, which
is imputed to
the device by manually pressing the eyecup from a remote position relative to
the housing
towards a close position and energy is stored as cocking energy within springs
in the device.
In Figure 2 the device is shown in active state before ejection, i.e., after
manual energy has
been inputted and the eyecup is in its active position ready for ejection.
The device 200 can be said to comprise a housing 210, having an externally
accessible
trigger 212 connected to a start pin 214 and lock pin 213. The housing also
comprises a door
214, which can be opened, when the eyecup is a remote position, for insertion
or replacement
of disc 216 with a plurality of containers 217 with openings 218 and peel
holes 219. An eye-
cup 220 comprises a rim 222 attached to an arm 224 which is connected in its
other end to a
hinge with a rotating axis penetrating into the housing and being connected to
its mechanism.
Said mechanism can be said to include a driving mechanism, generally
designated 230, a
cocking mechanism 240 a pump mechanism. 250, a peeling mechanism 260, an
indexing
mechanism 270 and a control system 280.
The eyecup arm is connected to a partial wheel 232 of the driving mechanism,
which
via a "locomotive" link 234 positively transmit the same rotation to driver
wheel 236. The
driver wheel is connected to a cocking wheel 242 of the cocking mechanism 240
via a free-
wheel system 23 8, arranged to allow concurrent rotation of the wheels when
cocking the de-
vice by pressing the eyecup towards the housing but freeing the cocking wheel
from the driv-
ing wheel when at opposite rotation. The driving wheel has an extension with a
slot 239 ar-
ranged for cooperation with the lock pin 213 of the trigger so that the
trigger, and accordingly
the eyecup, can be pushed when the driver wheel is flush with the slot, which
appears when
the eyecup is in the active position, but not when the lock pin is at the
extension outside the
slot.
The cocking wheel 242 of the cocking mechanism is connected to a lever 244,
which
can rotate around a lever hinge (not shown) as in the Figure 1 embodiment end,
allowing its
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
33
eyecup end to move up and down. The lover other end 246 is connected to a
damper as in
Figure 1. Downwards movement, away from the eyecup in the shown position, of
the lever
244 is used to cock separate springs in the pump mechanism and the peeling
mechanism.
The pump mechanism 250, substantially symmetrical around the device midline,
in-
cludes a ram 252 and the pump springs 254, arranged to throw the ram upon
release towards
the container 217 to eject liquid through the openings 219.
The peel mechanism 260, also substantially symmetrical around the device
midline,
similarly includes a peel pin 262 and the peel springs 264, arranged to throw
the pin, upon
release, towards the disc 216 to make the pin penetrate through the peel holes
219 of the disc
to thereby remove the temporary seal film. The release takes place when a
transmission hook
266 is freed by action of the trigger 212 via the start pin 214 and an
intermediate transmission
rocker 268. When this happens the cocking wheel is enabled for rotation in the
opposite di-
rection as compared to the cocking movement. At the end of the peeling
movement the pump
mechanism is activated to throw the ram.
The indexing mechanism 270 comprises an index wheel 272, for cooperation with
the
correspondingly shaped container disc hub, here shown with 14 teeth
corresponding to an
equal number of containers on the disc. The index wheel is connected to an
increment ar-
rangement 274, arranged to rotate the index wheel and disc an angle
corresponding to one
tooth. This is an incremental action initiated when the peel pin during
cocking of the device
arrives at its most remote position relative the eyecup part of the device, in
which position the
. .. -- . pin has been withdrawn from disc peel hole to enable its rotation:-
This action is also traps= ' "
mitted to a counter disc 276, which is also incremented to show a new
remaining doses figure
in a housing window and also to a gear wheel 278, which is given an
incremental rotation.
The gear wheel has a bolt 279, which after 14 doses ejected goes into contact
with the trans-
mission rocker 268 to relieve the transmission hook from the driver wheel,
hereby enabling
eyecup movement to a remote position beyond the active position, in turn
allowing opening of
the door for disc replacement.
Use of the device will be described from a start position in which the device
is cocked
with the eye-cup in the close rest position, where the trigger cannot be
pressed due to the lock
pin 213 being outside the slot 239. The eyecup is moved to the active position
where the trig-
ger can be pressed. The eyecup is placed against the eye and the trigger
activated which will
initiate a full sequence of peeling, ejection and indexing in a compulsory
manner by the ac-
tions described above. Upon release of the trigger the driver wheel 236 is
freed thereby the
eyecup and the springs associated with the driver wheel will move the eyecup
automatically
CA 02434201 2003-07-07
WO 02/062488 PCT/SE02/00150
34
to a remote position about 30 degrees out from the housing to urge the user to
perform a
cocking movement on the eyecup. The user pushes the eyecup to the close rest
position,
which cocks the device and at the end of the sequence also indexes the disc
and increments
the counter. The eyecup is locked in the rest position until it is actively
moved to the active
position for a repeated cycle. If 14 doses has been taken the eyecup is not
locked but can be
moved to a remote position where the door can be open for disc replacement.
The invention is not limited to the embodiments described and illustrated but
can be
varied within the scope of the patent claims.
