U.S. patent application number 10/414673 was filed with the patent office on 2004-01-15 for system and a method for modification of a device and a device suitable for modification.
Invention is credited to Genetay, Kerstin, Himbert, Hans, Hjertman, Birger, Pavlu, Bohdan.
Application Number | 20040010233 10/414673 |
Document ID | / |
Family ID | 30118949 |
Filed Date | 2004-01-15 |
United States Patent
Application |
20040010233 |
Kind Code |
A1 |
Hjertman, Birger ; et
al. |
January 15, 2004 |
System and a method for modification of a device and a device
suitable for modification
Abstract
A system and a method for modification of an manually operated
injection device. The injection device comprises a housing (1-3)
designed or suitable for manual gripping, a container for a
preparation attached to (6) or enclosed in the housing, an outlet
(4) for the preparation exposed with respect to the housing,
optionally a cap or guard (8) arranged for removable attachment
over the outlet and a mechanism arranged for moving the preparation
at least from the container through the outlet. The system
comprises a set of at least two elements (11,11') having different
properties in at least one respect. The elements (11,11') are
designed for mechanical attachment to one and the same area part
(3) of the housing, one at the time. The method includes the steps
of providing at least two elements (11,11') having different
properties in at least one respect, the elements being designed for
mechanical attachment to one and the same area part (3) of the
housing (1-3), one at the time, selecting one element (11) from the
set, and attaching mechanically the selected element (11) to said
area part (3) of the housing (1-3).
Inventors: |
Hjertman, Birger;
(Vallingby, SE) ; Himbert, Hans; (Bromma, SE)
; Pavlu, Bohdan; (Nacka, SE) ; Genetay,
Kerstin; (Drottningholm, SE) |
Correspondence
Address: |
DINSMORE & SHOHL, LLP
1900 CHEMED CENTER
255 EAST FIFTH STREET
CINCINNATI
OH
45202
US
|
Family ID: |
30118949 |
Appl. No.: |
10/414673 |
Filed: |
April 16, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60374348 |
Apr 22, 2002 |
|
|
|
Current U.S.
Class: |
604/187 ;
604/189; 604/227; D24/114; D24/133 |
Current CPC
Class: |
A61M 2205/583 20130101;
A61M 2205/6063 20130101; A61M 5/3129 20130101 |
Class at
Publication: |
604/187 ;
604/227; 604/189 |
International
Class: |
A61M 005/00 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 16, 2002 |
SE |
SE-0201142-7 |
Claims
1. A system designed for modification of an injection device, the
system comprising (I) a manually operated injection device, said
injection device comprising a) a housing (1-3) designed or suitable
for manual gripping, b) a container for a preparation attached to
(6) or enclosed in the housing, c) an outlet (4) for the
preparation exposed with respect to the housing, d) optionally a
cap or guard (8) arranged for removable attachment over the outlet
and e) a mechanism arranged for moving the preparation at least
from the container through the outlet, characterized in that the
system further comprises (II) a set of at least two elements
(11,11') the elements having different properties in at least one
respect, the elements (11,11') being designed for mechanical
attachment to one and the same area part (3) of the housing (1-3),
one at a time.
2. A system according to claim 1, wherein said elements are
different in at least one respect selected from the group
consisting of information carried, aesthetic properties, functional
properties, size and/or shape or combinations thereof.
3. A system according to claim 1, wherein each element (11,11') is
intended to be releaseably applied on said area part (3).
4. A system according to claim 1, wherein the inner face (12) of at
least one element (11) has a friction enhancing structure (13)
and/or a friction enhancing coating.
5. A system according any of claims 1 to 4, wherein at least one
element (11) is substantially U-shaped in a cross section view.
6. A system according to claim 5, wherein said element is arranged
to be brought into clamping engagement with said area part (3) of
the injection device.
7. A system according to any of claims 1-6, wherein at least one
element (11) has protrusions (14) projecting inwardly from its
inner face (12) and arranged to fixingly engage with complementary
shaped recesses (15) in said area part (3) of the injection
device.
8. A system according any of claims 1 to 4, wherein at least one
element (11) is a tubular shell, the inner face of which having a
configuration substantially conforming to the shape of said area
part (3).
9. A system according to any of claims 1-8, wherein at least one
element (11) comprises one or more material(-s) (16-18) more
pliable than the material of said area part (3).
10. A system according to claim 9, wherein said element (11)
includes an inner layer (16) of a first resilient material and a
superimposed layer (17) of a second elastic material softer than
said first material.
11. A system according to claim 9 or 10, wherein said element (11)
comprises an outer layer (17) having a outer face possessing a
friction enhancing structure and/or a friction enhancing coating
(18).
12. A system according to claim 10 or 11, wherein at least two of
the layers (16,17) of said element (11) are of mutually different
thicknesses.
13. A system according to any of claims 1-12, wherein at least one
element (11) includes at least one portion (21) having a thickness
substantially larger that the general thickness of said
element.
14. A system according to any of claims 1-13, wherein at least one
element (11) includes at least one portion (22) having a thickness
substantially smaller than the general thickness of said
element.
15. A system according to claims 13 and 14, wherein said element
has a contour (17,21,22) matching the palm and the fingers of the
user.
16. A system according to any of claims 1-15, wherein the outer
face (19) of at least one element (11) is provided with a pattern
(21), one or more colours, characters, a sign or the like.
17. A system according to any of claims 1-16, wherein at least one
element (11') is translucent, whereby a paper, sheeting, film or
the like (16') provided with a pattern, characters, a sign or
information positioned between said handle section (3) and the
element (17') is visible therethrough.
18. A system according to claim 16, wherein the outer face (19) of
said element (11) is provided with the name of the user, dosing
instructions, braille etc and/or a bar code.
19. A system according to claim 16 or 18, wherein the outer face
(19) of said element (11) is painted with a fluorescent dye.
20. A system according to any of claims 1-19, wherein a magnetic
tape, a liquid crystal thermometer (23), a blood sugar meter and/or
a digital watch is (are) integrated in the outer layer (17) of at
least one element (11).
21. A system according to any of claims 1-20, wherein
micro-ampoules (24) containing an aromatic substance are arranged
in the outer layer (17) of at least one element (11).
22. A system according to any of claims 1-21, wherein a heat
reflective sheet (25) is enclosed in the outer layer (17) of at
least one element (11).
23. A system according to any of claims 1-22, wherein a ring-shaped
mount, an eye, a protrusion (26) with a through hole (27), a clamp
or a similar device is firmly attached to or integrated in at least
one element for optional fastening of a string, a thread, a chain
etc carrying a charm, a mascot or the like.
24. A system according to any of claims 1-15, wherein said
protecting cap (8) has an outer face provided with a pattern, one
or more colours, characters, a sign or the like matching that of
the outer face of said element.
25. A system according to any of the preceding claims wherein the
element is shell-formed.
26. A method for modification of at least one manually operated
injection device, said injection device comprising a) a housing
(1-3) designed or suitable for manual gripping, b) a container for
a preparation attached to (6) or enclosed in the housing, c) an
outlet (4) for the preparation exposed with respect to the housing,
d) optionally a cap or guard (8) arranged for removable attachment
over the outlet and e) a mechanism arranged for moving the
preparation at least from the container through the outlet,
characterized in the steps of providing a set of at least two
elements (11,11') having different properties in at least one
respect, the elements (11,11') being designed for mechanical
attachment to one and the same area part (3) of the housing (13),
one at a time, selecting one element (11) from the set, and
attaching mechanically the selected element (11) to said area part
(3) of the housing (1-3).
27. A method according to claim 26, wherein each element (11,11')
is intended to be releaseably applied on said handle (3).
28. A method according to claim 27, wherein each element (11,11')
is substantially U-shaped in a cross section view and is arranged
to be brought into clamping engagement with said area part (3) of
the injection device by pushing the element (11) sideways over the
area part (3).
29. A method according to any of claims 26-28, wherein at least one
element (11) has protrusions (14) projecting inwardly from its
inner face (12) and arranged to be fixingly engaged with
complementary shaped recesses (15) in said area part (3) of the
injection device.
30. A method according to any of claims 26-29, wherein at least one
element (11) is a tubular shell, the inner face of which having a
configuration substantially conforming to the shape of said area
part (3) and arranged to be brought into squeezing engagement with
said area part (3) by pushing the element (11) lengthwise over the
area part (3).
31. A method according to any of claims 26-30, wherein at least one
element (11') is translucent and including the step of positioning
a paper, sheeting, film or the like (16') provided with a pattern,
characters, a sign or information between said handle section (3)
and the element (17') before arranging the element (11') over the
area part (3).
32. A method according to any of claims 26-31, including the step
of shaping the element (11) so that it matches the palm and the
fingers of the user.
33. A method according to any of claims 26-32, including the step
of providing the element (11) with the name of the user, dosing
instructions etc and/or a bar code.
34. A method according to any of claims 26-33, including the step
of attaching or integrating a magnetic tape, a liquid crystal
thermometer (23), a blood sugar meter and/or a digital watch to or
in an outer layer (17) of said element (11).
35. A method according to any of claims 26-34, including the step
of applying a heat reflective sheet (25) on at least a portion of
said area part (3).
36. A method according to any of claims 26-35, including the step
of attaching a ring-shaped mount, an eye, a protrusion (26) with a
through hole (27), a clamp or a similar device to said element (11)
for optional fastening of a string, a thread, a chain etc carrying
a charm, a mascot or the like.
37. A method according to claim 26, wherein the attachment step is
preceded by the step of removing another element from said area
part.
38. A method according to claim 37, wherein the removing step is
manual.
39. A method according to claim 37, wherein the removing step
includes the step of using a tool.
40. A method according to claim 26, wherein the attaching step is
manual.
41. A method according to claim 26, wherein the attaching step is
includes the step of using a tool.
42. A method according to claim 26, wherein the attaching step
includes the step of making the attachment permanent.
43. A method according to claim 26, wherein the attachment step is
preceded by the step-of removing said one element.
44. A method according to claim 43, wherein between the removing
step and attaching step the said one element is modified.
45. A method according to claim 44, wherein the modifying step
includes modification of information as defined.
46. A method according to claim 26, including the step of gripping
the injection device over at least a part of said one element.
47. A method according to any of claims 26 to 46, wherein the
element is shell-formed.
48. An injection device suitable for modification, said injection
device comprising a) a housing (1-3) designed or suitable for
manual gripping, b) a container for a preparation attached to (6)
or enclosed in the housing, c) an outlet (4) for the preparation
exposed with respect to the housing, d) optionally a cap or guard
(8) arranged for removable attachment over the outlet and e) a
mechanism arranged for moving the preparation at least from the
container through the outlet, characterized in that the housing has
at least one area part forming a site or seat to which is attached
a shell-formed element and that the housing and element are
mutually adapted to give a releasable attachment.
49. The device of claim 48, wherein the element is intended to be
applied on said area part (3) by a user of the injection device, in
that each shell-formed element (11,11') has a curved inner face
(12) possessing a configuration substantially conforming to the
shape of said area part (3), said shell-formed elements having
means (12-16) to be securely fastened to said area part (3), in
that said shell-formed elements (11,11') have a length essentially
corresponding to the length of said area part (3) and serving as a
grip for the injection device, and in that said shell-formed
elements (11,11') have an outer face (19) possessing a structure,
configuration and/or a function fulfilling personal requirements of
the user.
50. The device of claim 48 or 49, having any characteristic stated
in claims 1 to 25.
Description
[0001] Present invention is directed to a system and a method for
modification of an injection device, and an injection device
suitable for modification the injection device comprising a) a
housing designed or suitable for manual gripping, b) a container
for a preparation attached to or enclosed in the housing, c) an
outlet for the preparation exposed with respect to the housing, d)
optionally a cap or guard arranged for removable attachement over
the outlet and c) a mechanism arranged for moving the preparation
at least from the container through the outlet.
[0002] Existing portable multidose apparatuses or injection
devices, eg. pen-type injectors, generally consists of a first end
portion with an ejection outlet, e.g. a mounting for a needle
assembly, a second, opposite end portion possibly having a dosing
button, and an intermediate portion serving as a handle. Said
portions are integrated in a common shell-type housing of
non-flexible resin, preferably an injection moulded casing. The
design of the casing is adapted to protect the injector from
damages when being dropped on a floor or when being subjected to
bending or twisting forces, as the hard casing resists the
contemplated applied forces and shelters the mechanism of the
injector. However, all pen-type injectors of the same brand are
identical resulting in confusion which injector belongs to who when
two or more injectors at the same time and for some reason are
present in the same location. Further, different individuals may
need functional adaptations to there specific requirements, e.g. in
respect of added feature or adapted size and shape for gripping
parts. PCT application WO 98/55168 is directed to a manually
operated injection apparatus having an injection moulded housing
with an intermediate handle portion. A soft-touch semi circular
layer is firmly attached to a part of the handle portion by for
example a two-shot moulding or co-injection moulding process. This
means that the injection apparatus is obtainable with a permanently
fixed grip of a soft-touch semi circular, in cross section, layer.
However, this grip is of a standardized design and can not be
adapted to a users personal requirements or needs. Further, every
injection apparatus of the same brand looks alike and are hard to
distinguish from each other.
[0003] It is an object of present invention to provide an element
for a manually operated injection device, which is customized to
the user's personal requirements and wishes.
[0004] It is an other object of present invention to provide an
element for an injection device holding information concerning the
owner of the device, dose and kind of medical drug to be delivered
to the owner in case of emergency and other vital information.
[0005] A further object of present invention is to provide an
element for an injection device in which a metering device is
integrated.
[0006] These and other objects to be evident form the description
below are met by the characteristics set forth in the appended
claims.
[0007] Known in the art are various consumer articles, e.g. cell
phones etc., marketed with a plurality of add-on parts allowing the
article to be personalized or customized. Typically such add-ons
only serve an aesthetical but not a functional purpose.
Furthermore, faulty handling, misuse, unauthorized access or
inadvertent mix-up of different individuals articles does not cause
harm. In contrast, manually operated injectors may bring severe
harm if not properly handled before, during and after injection. A
patient identifying the wrong device is an obvious risk factor.
Preparatory steps may include for example needle attachment,
mixing, dose setting and deaeration of the preparation, arming of
the device etc. Critical steps in the mere injection phase can be
steady abutment to or penetration of the proper target site,
penetration to proper depth, possibly aspiration of body fluid,
delivery of full dose and withdrawal without residue. After the
treatment it may be necessary to remove a contaminated needle,
clean and reset the device, replace a preparation ampoule or store
the device with ampoule in a refrigerator. All such steps may cause
harm, e.g. by over or under dosing, destruction of tissue,
injection of air, transmittal of blood borne infections or
deactivation of drug. Manually operated injectors must be designed
for worst-case situations including self-administration also by
children, elderly and disabled persons, even when traumatized by
the injection procedure itself. Optimization of a design for all
possible patient and assistant groups is difficult, however. There
are individual variations in hand sizes, gripping patterns, body
postures and administration regimens. Patients dependent on daily
administrations also have a legitimate right for consideration to
individual variations in taste and preferences, e.g. for devices
that need to be brought around in daily life.
[0008] The present invention serves to solve the above-indicated
problems in connection with injection devices. The invention
provides a system and a method for modification of injector devices
allowing variation of device properties within broad ranges. The
invention offers a plurality of elements that can be attached to an
injector housing. With elements having different properties a
multitude of variations becomes possible for the housing part of
the device, which shall be illustrated and exemplified in the
detailed description below. Device size and/or shape can be
affected. For example, the size of the device can be adapted to the
size of individual hands, even continuously as for a growing child,
or to gripping habit variations such as when using precision grip,
as when using a pen, or force grip, as when using the hole fist.
Even adaptations to individual normal, disabled or injured hand
shapes become possible. Soft or sensitive materials can be used as
a worn or destroyed element can be replaced. Elements used e.g. at
gripping areas with textured surfaces can be removed and cleaned or
sterilized separately even when the injector as such does not stand
such treatment. Individual shapes can be used e.g. to allow
identification also by a blind patient. Size and shape variations
are possible also when the housing has a specific site for the
element, e.g. with locking or guiding structures, as the element
can extend beyond the site to varying degrees. The element can also
be used to carry information of general or individual character and
in human or machine readable form, the latter e.g. for security or
physician verification. Aesthetic variations of individual taste
can also be said to carry information. The element can also be used
to add a functional property as in case of metering devices. For
example, an element including a thermometer function, e.g.
including liquid crystals, may help a patient verifying that the
device is stored under suitable cold conditions, that it is not or
has not been exposed to drug destroying temperatures or that the
device has regained suitable temperature for injection. Further
examples will be given below.
[0009] As indicated, a manually operated injection device can be
said to comprise a) a housing designed or suitable for manual
gripping, b) a container for a preparation attached to or enclosed
in the housing, c) an outlet for the preparation exposed with
respect to the housing, d) optionally a cap or guard arranged for
removable attachment over the outlet and e) a mechanism arranged
for moving the preparation at least from the container through the
outlet. For description purposes the housing a) shall be regarded
as providing an "encasing" function whereas the other elements b),
c), d) and e) provides "operative" functions, not forming part of
the housing.
[0010] The principles of the present invention may be used for
injection devices or systems in broad terms utilizing various
delivery principles. The device may be of disposable design but is
preferably designed reusable. The device is manually operated in
the sense that it shall at least be gripped, typically in
connection with an injection step, but may also require additional
handling steps. The injector can be entirely manually operated,
e.g. wherein a control button is pushed to perform injection and
possibly also manipulated to set a dose etc. The device can be more
or less automatic with mechanical means, such as in autoinjectors,
or with electronic and motorized means. The housing shape can vary
depending on internal layout but shall have a basic form suitable
for gripping. It may have the elongated and even generally
cylindrical form known from injection pens. Although the elements
of the present system may add to housing ergonomics and convenience
properties it is preferred that can be manually operated also
without such elements, e.g. for minimum size in the hands of a
child. The container can be any type of single use, refillable or
replaceable. Syringe type containers can be used, such as ampoules,
cartridges, carpoules and syringes. The outlet from the device may
be an infusion channel or any conducting means such as a tube or
catheter, a needle or cannula or a needle-less system based on
liquid jet or a particle gun with gas propellant. As known per se
the outlet can be temporarily covered by a cap or, in connection
with needles, a displaceable needle-guard. The container content
material shall be deliverable by use of a delivery mechanism, also
referred to herein as a pump, 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. The nature of container
preparation content shall also be understood to include medical in
broad terms and to embrace for example natural components and body
fluids prefilled or drawn into the container although most commonly
the medical is factory prepared. The device can be used in
connection with medicals requiring a preparation step immediately
prior to the infusion, typically a mixing of two or more
components, which all may be fluid or may include a solid as when
dissolving a lyophilized powder in a solvent, such as hormones or
prostaglandins. The administration manner can also be varied within
broad limits and may include entirely continuous infusion,
continuous infusion with varying flow or intermittent infusions or
injections with repeated either equal or varying doses. In portable
devices the intermittent administration is common. Similarly,
although injection devices may be contemplated also for a single
dosing operation, generally they are designed for more than one or
multiple individual doses for intermittent administration. In
addition to the basic functions for delivery purposes the delivery
system with preference may include other valuable features such as
for initiating the container and its content and provide various
checks and controls of both the container and the pump part
electronics and mechanics. The mechanism for delivery of medical
through the container opening should basically include at least one
type of pump which may have to be selected for the special kind or
container and medical used. The pump may include any kind of
pressure source, such as mechanical or electrolytic pressure
build-up, in the container and suitable valve means for control,
which method can be used with virtually any kind of container and
any kind of product, such as transdermal delivery of powder,
similar delivery through liquid jets or regular tube infusion. The
common syringe type container need a specialized pump system.
Either the mechanism is adapted to act on complete syringes, having
their own piston rods or the mechanism has a piston rod acting more
or less directly on the piston of a cartridge type container, which
can be made smaller and more adapted to portable devices. Also dual
or multiple chamber cartridges can use similar devices for its
various phases.
[0011] The system of the present invention comprises at least one
injection device and a set of at least two elements, which elements
are different in at least one respect or property. The property may
be any of the above indicated shape, information or functional
respects but can be any other property as well. Preferably the
property is one that is significant for the user of the device and
most preferably a property that is significant to the user as an
individual. The existence of two, several or a plurality of
different elements means that a choice can be made and that the
device can be given different properties. This is not only an
advantage for the user. It also represents an advantage to a
manufacturer, supplier, vendor, wholesaler, retailer etc. since one
and the same basic device can be modified into several varieties,
which lowers costs, facilitates logistics etc. The minimum
requirement on the system is that there shall be a possibility for
such a modification. Devices may be delivered from the manufacturer
with an attached selected element or a standard element for
optional later replacement. Alternatively devices can be delivered
naked for later selection and attachment, e.g. at a vendor or a
physician. The attachment can be permanent, e.g. for security or
safety reasons, by use of for example interlocking means. The
attachment can be made releasable only by means of a tool, e.g. in
the possession of a physician for replacement or administration
instructions. The attachment can be arranged manually releasable,
e.g. to allow element replacement to the taste or in the discretion
of the user. It is clear that the three minimum components of the
system need not be at the same physical location to satisfy the
requirement for modification possibility although this is also a
possibility, e.g. if a kit of one injector device with several
alternative elements is delivered to the user. The system can also
be actually assembled, e.g. in case the housing has at least two
sites for the elements, occupied by different elements.
[0012] Housing and element are preferably mutually adapted for the
purpose of creating at least one specific site for the elements in
a set of such elements. When attached to the site the element
should be localized to that site. If movable when attached to the
site, the element shall have a range of movement limited to a
fraction of the housing dimensions. For most purposes it is
preferred that the element is immobile when attached to the site.
To this end the housing and/or the element can have guiding
structures. The housing may have a basic topology of irregular or
double-curved areas forming natural guiding structures for
correspondingly shaped elements. Special guiding structures may be
added, such as a rim, recess or platform to form a specific
structurally defined seat for the element. It is preferred that the
site or seat parts of the housing are designed so as to allow
handling of the injector also without an element attached and
preferably also these parts are sealed with respect to the housing
interior, by being covered or integral with the rest of the
housing, in order to prevent access or entrance of contamination
with or without an attached element. Similarly the elements may
have guiding structures fitting to housing details. Both parts can
have complementary structures keying into each other at attachment.
Although it is possible that the element is fixed to the site by
gluing, fusing or similar methods it is preferred that fixation
takes place by mechanical means, which among others facilitates
attachment, increases flexibility, allows replacement and avoids
contamination. Any known principles for mechanical attachment can
be used. Preferred are attachments based on shape and/or friction.
The shapes of housing and element may be such that the element
encircles the housing or a housing part to such an extent that
locking and release prevention are created, e.g. that the element
encircles a generally cylindrical or tube formed housing or housing
part to more than a half circle in cross-section as for a rings,
sleeves, clamps etc. Another shape-based attachment is use of
special locking structures of known kind, e.g. interlocking
structures, hooks and eyes, pins and grooves, protrusions and
undercuts etc. Alternatively or in addition friction can be relied
on, normally requiring a force as between interlocking structures
or between housing and element, the latter preferably in
combination with a design encircling the housing or housing part as
described and preferably with a design of the element such that it
has sufficient elasticity and pre-stress in its seated condition to
generate a clamping force. Friction increasing structures, textures
or material can be positioned on the housing site and/or preferably
on the element inner surface. As indicated above the mechanical
attachment can be designed for permanent fixation, tool releasable
fixation or preferably manually releasable fixation.
[0013] An element can be said to have an "inner" surface adapted
for attachment to the housing site and an "outer" surface exposed
to the user. It is normally the inner surface that is provided with
the attachment structures and features exemplified, although the
whole element may contribute as in case of clamping. A "set" of
elements shall be understood as a plurality of elements designed
for attachment to the same type of site, i.e. having sufficiently
similar inner surfaces or attachment characteristics to allow all
of them be attached to the same site. Also fulfilling the
requirements of a set are elements where a part can be exchanged,
e.g. a translucent or transparent cover part for exchange of
different sheets beneath although in most situations it is
preferred that that the entire element is exchanged. It is possible
that the housing has more than one site with the same kind of
attachment characteristics, allowing attachment of the elements in
a set to either or all such sites, e.g. two similar panels on each
side of the housing or encircling element structures at different
axial parts of the housing I is certainly also possible that the
housing has a second or more types of sites for a second or more
sets of elements having different attachment characteristics
compared to the first set, e.g. a first site type and set for
information and a second or more site types and sets for gripping
or any other function. Different caps or needle-guards may form one
or two sets of element within the present meaning. When having more
than one site type it is desirable the sets comprises elements that
match between the sets in functional, ergonomic and/or aesthetical
respects.
[0014] The attachment characteristics between housing and element
can be designed so as to allow attachment in a movable manner, as
indicated above, or at least to allow attachment of the element in
more than one way, e.g. to relieve the user from considering what
is left/right, front/rear etc. in case of symmetrically designed
elements. In many instances it is preferred that the elements can
be attached in only one fixed orientation, e.g. when dictated by
function or asymmetry. The outer surface of the element may extend
over substantially the same area as the inner surface or the
housing site or seat but may also extend beyond such an area, e.g.
for set of elements allowing variation of gripping areas, but the
elements may also have the same overall shape, e.g. for other
purposes. The nature of the outer surface is dependent on its
function, and variations will be evident from the exemplification.
The same applies for the overall shape of the element. A preferred
class of shapes is "shell" formed elements, meaning that they
substantially conforms to surface area of the housing and
essentially forms a continuation of the housing exterior when
attached although with slight deviations such as slightly recessed
or elevated or with about the same elevation, e.g. when placed in a
recess in the housing so as to make the element about flush with
the surrounding housing exterior. To act as a shell in this meaning
the element with preference is "thin" with respect to housing
dimensions, e.g. less than 6 mm, preferably less than 4 and most
preferably less than 2 mm. The shell can have varying cross-section
thickness over its surface but preferably the shell has about
constant cross-section thickness. The element or shell may cover
the entire housing although modification advantages are reached it
the element only occupies a part, e.g. less than 50% and preferably
less than 30% of the housing total area, for example when applied
only where functionally needed or sufficient for displaying
information. It is preferred that the element only partly encircles
the housing circumference. It is also preferred that the element
only partly extends along the housing axis. To be further explained
below, a shape found useful is a shell having substantially
U-shaped cross-section and designed to clamp around slightly more
than half a housing circumference and having an axial extension of
less than housing length but more than the diameter of the U-shaped
cross-section, preferably more than 2 and most preferably more than
3 timed the diameter.
[0015] Preferred embodiments of the invention are illustrated below
with reference to the accompanying drawings, in which:
[0016] FIG. 1 in an exploded side view shows a pen-type injection
device without the injection needle but exposing a needle mounting
and its protecting cap, whereby two elements according to present
invention are depicted below the handle section of the injection
device;
[0017] FIG. 2 illustrates the injection device of FIG. 1 in an
assembled state and with a grip means according to present
invention having a textured surface for gripping;
[0018] FIG. 3 illustrates the injection device of FIG. 2 but with
an outer face provided with an elected pattern;
[0019] FIG. 4 schematically depicts the injection device of FIG. 2
and with a grip means according to present invention having a
contour matching the palm and the fingers of the user of said
device;
[0020] FIG. 5 is a cross section view of an element according to
present invention;
[0021] FIGS. 6-14 are cross section views of alternative,
contemplated embodiments of an element according to present
invention, wherein FIG. 10 also is a cross section view along line
A-A and FIG. 11 also is a cross section view along line B-B in FIG.
4;
[0022] FIG. 15 is an elevation view of the embodiment in FIG. 12;
and
[0023] FIG. 16 is an exemplifying embodiment of an element
according to present invention having a protruding fastening
element for attaching a charm, a mascot or an anchoring chain to
the injection apparatus of FIG. 1.
[0024] Referring first to FIG. 1 illustrating a portable multidose
device in the form of a pen-type injector, said device generally
comprises an injection moulded casing or housing consisting of a
first end portion 1 and a second end portion 2. A handle section 3
or an area part of the housing serving as a handle is integrated in
the second end portion between the ends of the casing. An injection
outlet 4 is attached to the outermost end of the first end portion
1. In the illustrated embodiment the injection outlet is provided
with a mounting (external threads) 5 for fastening of an injection
needle (not shown) and has a cavity 6 adapted to receive an ampoule
or container (not shown) holding a drug or a medical preparation to
be self-injected by the owner of said injection apparatus. A
mechanism for injecting a dose of a drug is housed inside said
casing and FIG. 1 depicts a button 7 at the opposite end of the
casing serving both as a dosing device and a trigger for the
injection action. An optional protecting cap 8 is removably
attached to said first end portion and protects the injection
outlet when the injection device not is used.
[0025] The handle section 3 is encircled by an endless rib or ridge
9 defining a kind of seat and the ridge is integrated in the
casing. However, said seat is not mandatory for present invention
and in one presented embodiment of the invention (cf FIG. 6) it is
preferable eliminated, ie the ridge 9 is missing.
[0026] In order to customize the injection device to the user's or
owner's personal requirements, needs and to provide vital
information to medical personnel regarding the state of health or
treatment of the user an element 11 has been invented, which is
intended to be removable placed over the handle section 3 by the
user of an ordinary portable injection device, eg the pen-type
injector of FIG. 1. This personal element 11 is an essentially
shell-formed element having a curved inner face 12 possessing a
configuration substantially conforming to the shape of the handle
section or said seat and has a length corresponding thereto. Thus,
when mounted said element 11 preferably occupies the whole seat (if
any) and works as a grip for the injection device. In cross section
said element 11 is substantially U-shaped and is clamped over the
handle section, cf FIGS. 2 and 5. As shown in FIG. 5 said cross
section is more than semi circular and less than a full circle.
This means that, when applying the element 11 on the handle
section, the legs of the "U" is resiliently forced apart and then
they will spring back and clamp fastened to the handle section 3.
If the owner of the injection device wants to substitute the
element 11 he just has to bend it lose, remove it and put an other,
preferred element in its place, cf the substitute element 11'
depicted in FIG. 1, by pushing it sidways over the handle section
3. If, for any reason, the owner wants to keep the originally
chosen element he may of course fasten it by means of an
adhesive.
[0027] In above paragraph it is stated that the element 11 of
present invention is U-shaped in cross section. However, said
element may alternatively be of a substantially tubular design
having an inner face 12 conforming to the shape of the handle
section 3, schematically illustrated in FIG. 6. In this case the
element 11 is positioned by sliding it lengthwise over the casing
until it is in register with the handle section 3.
[0028] Referring now to FIG. 5 the element 11 preferably has a
friction enhancing structure 13, eg grooves, small protrusions with
sharp edges, particulate material integrated in the inner face 12
and so on, to eliminate the chance of the applied element sliding
on the slippery surface of the handle section 3. Alternately or in
addition to said structure the inner face 12 may be provided with a
friction enhancing coating, e.g. a layer of rubber-based
material
[0029] An other way of fixing the element 11 on the handle section
3 is by a detent-recess lock. An example of said fixation is
schematically illustrated in FIG. 7. A number of detents or small
pins 14 protrude from the inner face 12 of the element 11 to be
snapped into correspondingly shaped, interengaging recesses or
holes 15 in the handle section.
[0030] Referring to FIGS. 8 and 9 the element 11 according to
present invention alternately is composed of two or more materials
permanently joined in the axial direction and/or the radial
direction of said element. FIGS. 8 and 9 are cross section views
showing two examples thereof. When the element has more than one
layer the innermost layer 16 is of a more pliable material than
that of the handle section 3 but less than that of a superimposed
layer 17. As the innermost layer 16 works as an anchoring means it
is made of resilient material and is rather thin. The superimposed
layer 17 of elastic material is the actual grip portion and is
softer and thicker than the layer 16 to give the user of the
injection device a feeling of comfort and a steady holding of the
injection device, when used. Preferably, the superimposed layer is
a material possessing low thermal conductivity giving the user a
pleasant feeling of warmth when handling the injection device. FIG.
9 illustrates that, according to one embodiment of the invention, a
friction enhancing coating or layer 18 encloses the element 11.
This layer 18 is thinner than layers 16 and 17 to be easily
deformed and flexibly accompany any depression of the thicker layer
16 when the user squeezes the element 11. Alternately or in
addition to said layer 18 the outer face of the element 11
possesses a friction enhancing structure similar to the one
discussed above in conjunction with FIG. 5. Actually, all
embodiments of the element of present invention preferably has an
outer face made non-slippery, cf FIG. 2.
[0031] In order to better adapt the element 11 to the configuration
of the hand of the user-of the injection device or to his handling
ability or wishes the soft grip layer 17 may be provided with
portion(-s) 21 of a thickness larger than the general thickness of
the element 11 and/or with portion(-s) 22 of a thickness smaller
than the general thickness of the element, cf FIGS. 10 and 11,
respectively. Preferably the element is given a contour matching
the palm and fingers of the specific hand with which the user
handles the injection device, cf FIG. 4. Said contour is preferably
pre-made but could of course be configured afterwards.
[0032] To make it possible to distinguish injection devices of the
same brand from each other the elements according to present
invention are envisaged to be available with an outer face 19
having a specific pattern 28 and/or colour(-s) chosen by the owner
of the device, an example of which is presented in FIG. 3. When the
owner wants to give the device a new and different appearance he
has only to substitute said element.
[0033] Instead of or as a complement to the specific pattern 28
provided on the outer face 19 a sign, a bar-code, braille or
characters are suitable incorporated in the surface. Hereby it is
possible to display information regarding the owner of the
injection device and/or dosing instructions to the user. Thus, a
lost device is identified by the name and address printed on the
outer face of the element. Of still more importance is the
opportunity to provide the device with vital medical instructions
such as kind of drug administrated by the injection device, dosing
instructions, warning sign etc. This information would be very
helpful for a medical attendant who is to treat an unconscious
injection device user and could be a question of life and
death.
[0034] An other way to give personal information about the owner
and/or his medical needs is to produce the element 11 of a
translucent or transparent material 17' and position a paper,
sheeting film or the like 16', having said information and/or
pattern, between the handle section 3 and the element 11, whereby
the information is visible through the translucent layer 17' (cf
FIG. 8).
[0035] The element 11 according to present invention even offers
the opportunity to incorporate a chosen metering instrument in
accordance with the owner's wishes or needs, such as a liquid
crystal thermometer denoting the temperature of the drug ampoule, a
blood sugar meter enabling the user to test himself and/or other
benefical meters. Some persons would like to have a digital watch
or a magnetic tape with recorded information attached to the
device. As an example of this FIGS. 12 and 15 show an element 11
according to present invention having a thermometer 23 integrated
in said superimposed layer 17 and in level with said outer face
19.
[0036] It is also possible to give the injection device a specific
(parfume) scent by enclosing micro-ampoules 24 containing an
aromatic substance in the outer layer, eg said superimposed layer
17, as illustrated in FIG. 14.
[0037] Some persons appreciate a warm grip on an injection device
and FIG. 13 depicts a heat reflective sheet 25 enclosed in the
outer layer 17 adjacent to or at the outer face 19 of the element
11.
[0038] It is also popular among some groups of persons to have a
personal item dangling from a belonging. This demand is fulfilled
according to present invention by a ring-shaped mount, an eye, a
protrusion with a through hole, a clamp or a similar device which
is firmly attached to or integrated in said element for optional
fastening of a string, a thread, a chain etc carrying a charm, a
mascot or the like (not shown).
[0039] Thus, FIG. 16 shows a protrusion 26 with a through hole 27
arranged on the outer face 19 of the element 11. A similar
attachment can alternatively be arranged on the housing itself,
e.g. at the rear not to interfere with handling of the device.
[0040] Preferably said protecting cap 8 of the injection device has
an outer face provided with a pattern, one or more colours,
characters, a sign or the like matching that of the outer face of
the element 11.
[0041] A variety of embodiments of present invention have been
exemplified in the description and the drawings and the features
presented therein may of course be optionally combined in the
element of present invention according to the requirements of the
user of the injection device.
* * * * *