U.S. patent application number 10/850230 was filed with the patent office on 2004-10-28 for liquid delivery device and method of use thereof.
Invention is credited to Gremion, Emmanuel, Himbert, Hans, Kaser, Stefan, Peclat, Christian, Saurer, Alain, Siegfried, Daniel, Villiger, Beat.
Application Number | 20040215157 10/850230 |
Document ID | / |
Family ID | 27354660 |
Filed Date | 2004-10-28 |
United States Patent
Application |
20040215157 |
Kind Code |
A1 |
Peclat, Christian ; et
al. |
October 28, 2004 |
Liquid delivery device and method of use thereof
Abstract
A device and use method for ejecting a liquid stream towards an
eye, the stream moving from a proximal position towards a distal
position, 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 opening to form the stream and e) an
eyecup with a contact surface arranged for contact with the eye or
its facial surroundings. The eyecup is arranged movable with
respect to the opening or housing between at least two positions i)
an active position with said eyecup contact surface at a defined
safety distance to the opening and ii) a rest position with the
eyecup contact surface at a position more proximal than in the
active position and a sensor is arranged to allow discrimination
between the positions. 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, whereby a driving
mechanism is arranged to transform manual or stored energy both i)
into cocked energy of the pump driver and ii) into direct or stored
energy for operation of the activation mechanism.
Inventors: |
Peclat, Christian;
(Neuchatel, CH) ; Gremion, Emmanuel; (Echarlens,
CH) ; Saurer, Alain; (Neuchatel, CH) ;
Siegfried, Daniel; (Bern, CH) ; Kaser, Stefan;
(Aarau, CH) ; Villiger, Beat; (Reinach, CH)
; Himbert, Hans; (Bromma, SE) |
Correspondence
Address: |
DINSMORE & SHOHL, LLP
1900 CHEMED CENTER
255 EAST FIFTH STREET
CINCINNATI
OH
45202
US
|
Family ID: |
27354660 |
Appl. No.: |
10/850230 |
Filed: |
May 20, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10850230 |
May 20, 2004 |
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10071825 |
Feb 7, 2002 |
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6758837 |
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60328551 |
Oct 11, 2001 |
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Current U.S.
Class: |
604/294 |
Current CPC
Class: |
A61H 35/02 20130101;
A61F 9/0008 20130101; A61F 9/0026 20130101 |
Class at
Publication: |
604/294 |
International
Class: |
A61M 035/00 |
Foreign Application Data
Date |
Code |
Application Number |
Feb 8, 2001 |
SE |
0100418-3 |
Claims
1-44. (Cancelled).
45. A device for ejecting a liquid stream, the stream moving from a
proximal position towards a distal position, 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, including a
pump driver able to store cocked energy for driving the pump
mechanism, operable to deliver at least part of the liquid from the
container through the outlet to form the stream, e) at least one
activation mechanism operable to drive an indexing action in which
a container is brought into operative relationship with the pump
mechanism and to drive a peeling or breaking action in which a
temporary seal is removed from the container or broken, and f) a
driving mechanism adapted to transform manual or stored energy both
i) into cocked energy of the pump driver, and ii) into direct or
stored energy for operation of the activation mechanism.
46. The device of claim 45, comprising one or more mechanical
springs adapted to store at least part of the cocked energy.
47. The device of claim 45, wherein the driving mechanism comprises
a transmission.
48. The device of claim 47, wherein the transmission is adapted to
perform gear down from lower to higher force.
49. The device of claim 45, wherein the driving mechanism is
adapted to receive manual energy.
50. The device of claim 49, wherein the driving mechanism comprises
a transmission.
51. The device of claim 50, wherein the transmission is adapted to
perform gear down from lower to higher force.
52. The device of claim 45, wherein the driving mechanism is
adapted to receive stored energy.
53. The device of claim 52, wherein the stored energy comprises
electrical energy.
54. The device of claim 53, wherein the driving mechanism includes
an electric motor.
55. The device of claim 54, wherein the driving mechanism comprises
a transmission.
56. The device of claim 55, wherein the transmission is adapted to
perform gear down from lower to higher force.
57. The device of claim 53, further comprising an electronic
control system.
58. The device of claim 45, wherein the peeling action comprises
moving a de-sealing tool through a disc member having a plurality
of containers.
59. The device of claim 58, wherein the peeling action includes
control of presence of a temporary seal before its removal.
60. The device of claim 45, wherein the driving mechanism is
adapted to cock stored energy for driving the activation
mechanism.
61. The device of claim 45, wherein the driving mechanism is
adapted to drive the cocking and activation mechanism at least
partly in sequence.
62. The device of claim 61, wherein the activation mechanism is
adapted to drive at least two actions at least partially in
sequence.
63. The device of claim 45, wherein the device further comprises an
eyecup with a contact surface arranged for contact with the eye or
its facial surroundings.
64. A method for operating an ejection device for ejecting a liquid
stream, the stream moving from a proximal position towards a distal
position, 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, including a pump driver to store cocked energy for
driving the pump mechanism, operable to deliver at least part of
the liquid from the container through the outlet to form the
stream, and e) at least one activation mechanism operable to drive
an indexing action in which a container is brought into operative
relationship with the pump mechanism and to drive a peeling or
breaking action in which a temporary seal is removed from the
container or broken, the method comprising operating a driving
mechanism to transform manual or stored energy both i) into cocked
energy of the pump driver, and ii) into direct or stored energy for
operation of the activation mechanism.
Description
TECHNICAL FIELD
[0001] The present invention relates to devices and methods for
ejecting a liquid stream, in particular towards an eye, the stream
moving from a proximal position towards a distal position, 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 opening to form the stream and e) an eyecup with a
contact surface arranged for contact with the eye or 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
[0002] Devices for 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 or treatment of the body surface such as topical
treatment. For reasons to be explained, aspects of the present
invention have special utility in ophthalmology and especially in
liquid treatment of and eye. For convenience and unless otherwise
indicated the invention will be described in terms of this
application although aspects of the invention has broader
utility.
[0003] 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 for immersion of
the eye. Delivery 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 or encourage frequent use, also in
self-administration situations. A common application is the
administration of medical to the eye. 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 improper physiological effects
from absorbency in non-target tissues or drainage of excess amounts
through the tear channel into the throat cavity or the
inconveniences caused by over-flow on face and clothes. Also price
considerations apply for expensive medications. As an example, the
treatment of glaucoma requires frequent daily administrations of
e.g. prostaglandins, 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.
[0004] The circumstances mentioned place severe demands on a device
for the general purposes 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. Typically also secondary steps have to be mastered, such
as initiation steps and control of device status and preparation
condition.
[0005] 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 responsibility 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 administration, 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 convenience is kept simple and inexpensive
to allow for widespread distribution and inclusion also in
disposable devices.
[0006] 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 98/55059 and U.S.
Pat. No. 5,607,410 having features for convenient use or compact
transport form respectively. 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 operation, typically
involving release of stored energy, e.g. for controlled initiation,
triggering, 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 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 pressurized
chamber through a narrow orifice. Devices of this kind are
described in for example in WO 96/00050 for multiple dose
containers and in WO 96/06581 and our co-pending application
PCT/SE00/01514 for single dose containers. The disclosed proposals
of this kind are not optimized for use as portable or handheld
devices, neither in respect of convenience features nor in respect
of suitability for further automation.
[0007] 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 mistakes 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 THE INVENTION
[0008] 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 specific
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 further 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 multi-dose or single dose containers. A
further object is to provide a device suitable for use with one or
several replaceable single-dose or multi-dose containers. Still
another object is to provide devices as of suitable secondary
properties, outside the immediate treatment situation, such as
recharging, initiation, control, cleaning, handling and
manufacture. Yet another object is to provide devices as above
suitable for liquid delivery to an eye. A further object is to
provide an 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.
[0009] These objects are reached with the characteristic features
set forth in the appended patent claims.
[0010] According to one aspect of the present invention the device
is arranged for liquid delivery 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, improving
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 integration 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 accordingly, 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
removable arrangement, e.g. for facilitating cleaning or allowing
replacement or selection between different eyecup shapes or sizes.
The mobility 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 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.
It is clear that the functionality 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 specific movable parts are made movable in
corresponding manners.
[0011] According to another aspect of the present invention the
device comprises an activation 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 ejection 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 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
multi-dose containers, with single or plural container arrangements
and with fixed or replaceable such containers. Peak force or energy
requirements can be reduced if the two transformations 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 directly operates
the activation mechanism or that the driving mechanism provides
stored energy 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.
[0012] Further and more specific objects and advantages will be
evident from the detailed description below.
Definitions
[0013] Unless clearly referring to a specific detail, as used
herein "system" shall be understood to refer to the principles of
the invention generally, whether described, claimed, exemplified or
implemented as one or more devices/arrangements, methods, uses or
combinations thereof.
[0014] 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 "connected", "attached", "arranged",
"applied", "between" and similar terminology shall not be
understood to cover exclusively direct contact between the recited
elements but shall be understood 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. Similarly, in the absence of explicit statements or
obvious conditions to the contrary, such expressions 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.
[0015] 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 "forward" 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 delivered in the forward direction.
[0016] 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
[0017] 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 mixtures, 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 constraints are more severe
than in most other applications. For convenience the invention will
be described in terms of this application.
[0018] Normally the material to be delivered is a fluid and
preferably a liquid, including materials 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 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.
[0019] 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 conducting
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 material 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 material is a fluid and
preferably a liquid, including materials behaving as liquids such
as emulsions or suspensions. These observations relates to the
final preparation whereas other components, notably solids, may be
present before final preparation.
[0020] 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
ambulatory 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
[0021] 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
container 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
[0022] 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 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.
[0023] 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 container
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 possible 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 further 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.
[0024] The container may be a simple bottle, vial or bag in case
the delivery device is arranged 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 syringe type of delivery
system, which may be still more elaborate in the case of
multichamber cartridges. Cartridge type containers shall be further
described as they generally require additional initiation or
control steps for which the principles of the invention with
preference can be exploited.
[0025] A cartridge for the present purposes may generally be said
to include a vessel having a front part and a rear part defining a
general cartridge axis, an outlet for the preparation arranged at
the front part and at least one movable wall arranged at the rear
part, a displacement of which wall causes the preparation to be
moved towards or expelled through the outlet. Vessel 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. Preferably, however, the vessel has a
substantially constant internal cross-section , with a similarly
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, although 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 arranged 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 connection
be provided with a breakable or penetrable sealing.
[0026] 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 reshaping 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 deformations 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 outlet devices or needles.
[0027] Dual or multi chamber cartridge types are known e.g. for
preparations demanding a mixing of two or more components or
precursors before administration. The components are 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, 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 lands in a manner allowing by-flow of
rear chamber content into front chamber at displacement of the rear
movable wall (compare e.g. U.S. Pat. No. 4,968,299 or WO 93/20868
and WO 95/11051). 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.
[0028] Initiation of the multi-chamber type cartridges requires all
the general type steps described, although in aggravated form due
to the additional walls and spaces present. In order to provide for
efficient 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
multi-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.
[0029] 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 contamination
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 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 U.S.
Pat. No. 2,642,062, U.S. Pat. No. 3,419,007 and U.S. Pat. No.
5,026,343 and for eye treatment as exemplified by WO 96/06581 and
our co-pending application PCT/SE00/01514 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 surrounding 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 towards 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 substantially 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.
[0030] Although the above considerations apply to individual
containers for single and discrete 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 package is a
substantially rigid and self-bearing structure, among others giving
advantages in connection 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 mentioned by providing an enlarged front wall
structure and provide several cavities in the structure, 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 undivided sheet material can then be
attached to several, and preferably all, of the individual
containers 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.
[0031] 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 device
design. The shape may for example be rectangular, square 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.
[0032] Most container types can be arranged in multiple
arrangements if desired and an initiation 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.
[0033] 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 rupturable seal can be used it is often preferred to use
a removable seal in order to avoid any particle 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 preferably attached to the front surface of the front
wall. It is preferred to avoid glue and adhesives and preferably
some form of welding is used, as by ultrasonic or heat. In order to
facilitate 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 or separate 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
[0034] The opening design can vary depending on the nature of the
liquid stream to be produced, 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, converging,
e.g. for assisting in a coherent stream to be formed, or a
combination, such as a venturi type of channel. In high speed
applications it is generally preferred to make the duct part 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 syringe.
The Pump Mechanism
[0035] The mechanism for delivery of medical through the container
opening should basically include at least one type of pump
mechanism which may have to be selected for the special kind or
container and medical used. The pump mechanism may include any kind
of pressure 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
container and any kind of product, such as transdermal delivery
through liquid jets, as exemplified 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 centrifu gal
action, although 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 U.S.
Pat. No. 5,480,381 for liquid jet or U.S. Pat. No. 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 U.S. Pat. No. 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 exemplified 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 devices for its various phases, as
exemplified by the WO 93/02720. 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.
[0036] 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.
[0037] The pump mechanism may also include a manual control,
forming the interface between 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 control 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 reduced 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.
[0038] 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 adhered to a
surface is thrown by vibration 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, U.S. Pat. No. 5,518,179 and
U.S. Pat. No. 5,838,350 and bubble jet technique for eye treatment
in WO 94/03135. Such pump mechanisms can be used for the present
purposes, especially for delivery of small drops as sometimes
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.
[0039] 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 arrangement. 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 arrangements as in
aspiration/ejection systems or pistons in syringe type devices.
[0040] 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.
[0041] Similarly the energy input to the driving mechanism can take
various forms. The energy can be manual. Alternatively stored
energy in any form can be used, e.g. the above said firms although
the energy preferably is electric, e.g. externally delivered to the
device or preferably in an on-board battery, to be transformed by
any electromechanical device such as a solenoid or preferably an
electric motor.
[0042] 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 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
[0043] As indicated above the various container types may need
different initiation actions. For example a syringe type container
may need an initial piston movement for various reasons such as
mixing of precursor components. A piston/cylinder 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
temporary seals may be needed, herein also referred to as peeling.
All possible initiation steps shall here not be repeated.
[0044] Additional initiation steps can be said to include control
steps performed to avoid malfunction 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-switches or simple mechanical locks or catches but to the
extent these controls need movement of parts requiring significant
force or power these steps can be treated as initiation steps
below.
[0045] 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 the 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 arrangement can then be used for both purposes. Alternatively,
e.g. if the force or speed requirements 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 actions need different movement characteristics or are
applied to different parts, requiring at least some different parts
in the driver mechanism, which often is preferred.
[0046] 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.
[0047] 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 arrival before the
plunger becomes 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. Normally,
however some shift arrangements are needed for sequencing.
Typically the driver system 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 continued movement or by reversing motor
operation. Similar actions, including different arrival times, can
be used for sequencing between several initiation action.
Operation Control
[0048] Operation of the device can be said to include the necessary
steps for ejection of the liquid, initiation steps and control
steps when present and any interaction thereof such as sequencing
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
operated 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.
[0049] 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 positions.
Nothing prevents use of combined software and mechanical
arrangements for highest safety and operation redundancy.
[0050] 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.
[0051] 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 mechanical springs are utilized.
[0052] Detail regarding use of sensors and signal processing in the
device for the device will be given below in connection with
description of eye cup mobility since the general principles there
given is equally applicable for other parts of the device.
Uses
[0053] 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 desirable to
replace manually operated pump mechanisms with some kind of
automated operation, 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 autoinjectors, 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 pressurized
chamber through a narrow orifice. The eye treatment application
will be further described below.
Eye Treatment
[0054] 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 expensive
treatment medical but also in potential side-effects when
non-absorbed preparation is drained away via the nasolacrimal 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 at least introduce a high degree of uncertainty. Also
the common methods do not provide an high degree of targeting
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 determined 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 although 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 container contains a single unit dose, these
figures also relate to the liquid volume charged and contained in
the containers, possibly allowing for some overfilling to
compensate for non-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 m/s. Generally the speed is
lower than 200 m/s and preferably lower than 100 m/s. A suitable
drop size so defined should be sufficient 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 droplets 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 values 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
independent of liquid viscosity and tend to apply both for
solutions and ointments.
The Eye Cup
[0055] 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 operator from these responsibilities. A
suitable eye cup part comprises at least a rim and a cavity.
[0056] 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 centering is obtained if the rim make contact with
the eye socket. The "rim" shall be understood 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 purposes of description it is assumed that a
line can be drawn so as to connect the contact points 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 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 of an ellipse, adapted in
size and shape to the eye socket, can for example be used. The
contact 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.
[0057] 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 understood 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 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
extending away from the rim in a direction opposite the contact
direction, although two or several 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
contact, 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.
[0058] The eyecup may include auxiliary features such as details
assisting proper use and targeting, e.g. some fixation point for
the eye, for example a mirror, a light etc.
Eye Cup Mobility
[0059] When using an eyecup it is preferred to arrange it movable
with respect to the housing. 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 arranged fixed with respect to
the housing, certainly with maintained options for container
replacement or movement of plural containers to and from an active
site. The eyecup can be movable into 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 are satisfied, e.g. so
that the eyecup contact direction has at least a movement component
along the opening axis. The movement can be purely translational or
may have a rotational component, the latter preferably 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.
[0060] 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.
[0061] 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 signal 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.
[0062] 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 considerations 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.
[0063] 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 components can be of any kind although some typical
examples will be given below. Also the control signal can be of any
nature, such as mechanical, optical etc., dependig on its further
use.
[0064] 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 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.
[0065] 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 device
respectively, dependent on the proper eyecup condition. The
enabling/disabling may take 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 properly
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.
[0066] 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.
[0067] It is preferred that the device is arranged to take at least
one in the initiation and ejection 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.
[0068] 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 including mechanical but preferably electric
control of the dose delivered. In jet injectors sensors 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 multichamber 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
[0069] Below some considerations will be given for a use example in
which a device is arranged to utilize the container types described
above with reference to our co-pending application PCT/SE00/01514
and especially the described multiple container arrangement in the
general revolver type disc layout.
[0070] 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 in
the seat, an actuator arrangement operative to drive the ram.
[0071] 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 ram,
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. Preferably 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,
although 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. by having a track in which the
structure can be moved in one or two dimensions. In the preferred
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 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 arrangements 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 preferably 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 used or
remaining and warning for or preventing reuse of already emptied
containers.
[0072] 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. This can be done
with a soft and adaptable ram head, e.g. for the purposes of being
compatible 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 central,
axial, parts which can be done for example by making the soft ram
head slightly shallower in shape than the shape of the cavity
vessel form. For a single cavity form it is, however, 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 ran is generally not critical
to the dynamics of the ejection but rather for propulsion and will
be described in connection with the actuator system.
[0073] 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 preferred to provide
an leverage or gear exchange to amplify or transform force or
speed, preferably towards lower speed and higher force. In order to
have controlled and consistent results it is generally preferred 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
generator, 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
motor 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 preferred
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 transmission. It is
preferred that at least the ram head, and preferably parts of the
ram piston, are prevented 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.
[0074] It is also preferred to include in the device arrangements
to facilitate breakage or removal 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 active step to break the seal. This can be done
by having a de-sealing tool arranged in connection 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 desealing tool can be operated manually or
automatically or compulsory, e.g. as a part of the 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 interference with the ejection area and
ejection target but most preferably
[0075] 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 removal 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. Preferably 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 alignment 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 removed.
It might also be of interest to use different movements
characteristics for the two steps, egg. 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 brake or damper etc. The general container
design principles of the present invention strongly amplifies 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 instability
problems.
[0076] A device as exemplified can be adapted for different uses.
Depending on each application it may be beneficial to equip the
device with arrangements assisting targeting and positioning. 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 between opening and target
surface, and possibly an arrangement for device triggering at a
certain 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
[0077] 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
[0078] FIG. 1A shows in exploded view and FIGS. 1B to 1G 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. FIG. 1H shows in greater detail the
components of the main lever.
[0079] FIGS. 2A to 2C show schematically in an open view and in two
cross-sections respectively an alternative embodiment of an
entirely mechanical device which is arranged to be cocked by manual
energy.
DESCRIPTION OF DRAWINGS
[0080] FIGS. 1A to 1H 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.
[0081] FIG. 1A 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
comprises a window 124 over a display and a battery closure
125.
[0082] The housing interior has a chassis upper part 126 and a
chassis lower part 127 carrying the device mechanism. Said
mechanism can be said to include a driving mechanism, generally
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 system 180, including a board
181 for electronics.
[0083] 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 and an external
screw-thread 133 for cooperation with the upstream gear wheel in
the transmission chain. The motor and detectors for motor
revolutions are attached to the electric board 181.
[0084] The transmission 140 can be said to comprise a set of gear
wheels in a gear train arranged 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 parts 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 FIG. 1H for details.
[0085] The pump mechanism 150 can be said to include a lever 152,
which can rotate around 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 arrangement the piston is
moved against vacuum and bleeding of air into the cylinder, for
retarding 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 container 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 FIG.
1H, the lever has a nut 151, with internal screw-threads (not
shown), for cooperation with corresponding 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 position and
accordingly completed peeling.
[0086] 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 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 described 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 presence.
[0087] 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 162 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 correspond 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 movement 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 decrement 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.
[0088] 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 mentioned cam surfaces in
bearing 128' for detection of eyecup position. A switch 189 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.
[0089] FIG. 1B to 1F show the various phases of the device
operation. FIG. 1B corresponds 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 the cock springs 156 are already in a cocked
state, which cocking has taken place earlier during a rearward
movement of the peel pin, and the damper 157 is in its initial
position. In the Touch foil position shown in FIG. 1C 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 FIG. 1D the peel pin
162 has completed its forward movement and removed the foil. In the
Injection position of FIG. 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 ejection in the position shown.
The lever 152 has moved up to the right in the Figure, under
influence of the cock springs 156, and down to the left under
withdrawal of the damper 157 piston. In the Start index position of
FIG. 1F the device has been re-cocked during return movement of the
peel pin, by again reversing the motor and the peel pin in a more
rearward position than in FIG. 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
FIG. 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
shown active position. Alternatively, as shown in the Open cover
position of FIG. 1G, the processor may move the peel pin to a still
more rearward position than in the Start index position shown in
FIG. 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 swung 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.
[0090] Use of the device will be described from a start position in
which the device is in the Standby position as shown in FIG. 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 sequence of peeling, ejection and indexing in a compulsory
manner by the actions described above until the device is again in
the state of FIG. 1B. Alternatively the trigger activation will
only make the device proceed to full peeling of the foil as
illustrated in FIG. 1D. Then a new trigger action will be needed to
complete ejection as shown in FIG. 1E and automatically proceed to
full completion as illustrated in FIG. 1B or to the Open cover
position of FIG. 1G. The second triggering shall be made within a
certain time frame from the first 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 consumed the processor will activate the
motor to drive the peel pin to its rearmost position as shown in
FIG. 1G for disc replacement. After detection of a fresh disc the
processor will move the peel pin to the Standby position shown in
FIG. 1B and the doses counter will be reset.
[0091] FIGS. 2A to 2C depict an overview of a modified device as
compared to that of FIG 1 and the following description will mainly
focus on the differences. The FIG. 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
FIG. 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.
[0092] 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 eyecup 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.
[0093] 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 238, arranged to allow concurrent rotation of the
wheels when cocking the device by pressing the eyecup towards the
housing but freeing the cocking wheel from the driving wheel when
at opposite rotation. The driving wheel has an extension with a
slot 239 arranged 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.
[0094] 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 FIG. 1 embodiment end, allowing its eyecup end to move up
and down. The lover other end 246 is connected to a damper as in
FIG. 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.
[0095] The pump mechanism 250, substantially symmetrical around the
device midline, includes 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.
[0096] 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 direction as compared to the
cocking movement. At the end of the peeling movement the pump
mechanism is activated to throw the ram.
[0097] 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 arrangement 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 transmitted 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
transmission 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.
[0098] 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 trigger 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 actions 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
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.
[0099] The invention is not limited to the embodiments described
and illustrated but can be varied within the scope of the patent
claims.
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