U.S. patent application number 10/458348 was filed with the patent office on 2004-04-15 for cases for medication delivery devices.
Invention is credited to Lussier, Sherin, Penney, Melinda, Tomellini, Dalita R..
Application Number | 20040069667 10/458348 |
Document ID | / |
Family ID | 26898995 |
Filed Date | 2004-04-15 |
United States Patent
Application |
20040069667 |
Kind Code |
A1 |
Tomellini, Dalita R. ; et
al. |
April 15, 2004 |
Cases for medication delivery devices
Abstract
Cases are provided for carrying medication delivery devices such
as auto-injectors, syringes or vials. The cases include a cradling
structure to protect the medication delivery device from jostling
and impact encountered during transport.
Inventors: |
Tomellini, Dalita R.;
(Rehoboth, MA) ; Lussier, Sherin; (North
Providence, RI) ; Penney, Melinda; (Providence,
RI) |
Correspondence
Address: |
FISH & RICHARDSON PC
225 FRANKLIN ST
BOSTON
MA
02110
US
|
Family ID: |
26898995 |
Appl. No.: |
10/458348 |
Filed: |
June 10, 2003 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10458348 |
Jun 10, 2003 |
|
|
|
09853501 |
May 11, 2001 |
|
|
|
6595362 |
|
|
|
|
60203880 |
May 12, 2000 |
|
|
|
Current U.S.
Class: |
206/364 ;
206/366 |
Current CPC
Class: |
B65D 2313/02 20130101;
B65D 25/105 20130101; B65D 85/20 20130101; A61M 5/002 20130101;
B65D 43/164 20130101 |
Class at
Publication: |
206/364 ;
206/366 |
International
Class: |
B65D 083/10 |
Claims
What is claimed is:
1. A case for a medication delivery device comprising: a container
body defining an open chamber constructed to receive the medication
delivery device; a lid constructed to cover the open chamber; and a
cradling structure, within the chamber, constructed to hold the
medication device securely in a predetermined position during
transport of the case.
2. The case of claim 1 wherein the cradling structure comprises a
cradle having a curved surface.
3. The case of claim 2 wherein the curved surface has a curvature
that substantially corresponds to the curvature of a curved portion
of the medication delivery device.
4. The case of claim 2 wherein the cradling structure further
comprises a foam layer covering at least a portion of the curved
surface of the cradle.
5. The case of claim 1 wherein the cradling structure further
comprises a cradle guide.
6. The case of claim 1 wherein the cradling structure is
constructed so that the medication delivery device press-fits into
the cradling structure.
7. The case of claim 1 wherein the cradling structure is
constructed so that the medication delivery device will not fall
out of the cradling structure when the lid is open and the open
chamber is inverted.
8. The case of claim 1 further comprising a hinge joining the lid
to the container body.
9. The case of claim 8 wherein the hinge is constructed to allow
the lid to stay open without being held open.
10. The case of claim 1 wherein the medication delivery device
comprises an auto-injector.
11. A case for a medication delivery device comprising: a container
body defining an open chamber constructed to receive the medication
delivery device; and an encapsulating member, disposed at an end of
the open chamber, defining a receptacle constructed to receive an
end of the medication delivery device.
12. The case of claim 11, wherein the receptacle includes a portion
for receiving a needle.
13. The case of claim 12 wherein the needle-receiving portion
includes a foam.
14. The case of claim 13 wherein the needle-receiving portion
further includes a hard, puncture-proof shell surrounding the
foam.
15. The case of claim 11 wherein the receptacle includes a portion
for receiving a proximal end of the medication delivery device, and
preventing force from being applied to the proximal end during
storage of the medication delivery device in the case.
16. The case of claim 11 wherein the receptacle is constructed to
pivot between a first position in which the receptacle is within
the chamber and its long axis is parallel to a long axis of the
case, and a second position, in which at least a portion of the
receptacle extends out of the chamber.
17. The case of claim 16 wherein the receptacle is constructed to
pivot through an angle of about 90 degrees.
18. The case of claim 11 further comprising a biohazard label.
19. The case of claim 11 further comprising a lid constructed to
cover the open chamber.
20. The case of claim 11 further comprising a cradling structure,
within the chamber, constructed to hold the medication device
securely in a predetermined position during transport of the
case.
21. A case for a medication delivery device comprising: a container
body defining an open chamber constructed to receive the medication
delivery device; a lid constructed to cover the open chamber; a
cradling structure, within the chamber, constructed to hold the
medication device securely in a predetermined position during
transport of the case; wherein the container body includes a
connecting device, for connecting the container body to another,
similar container body, and a receiving portion, for receiving a
corresponding connecting device of another case.
22. The case of claim 21 wherein the connecting device includes a
clip member and the receiving device includes a slot dimensioned to
receive the clip member.
23. The case of claim 21 further comprising a lid constructed to
cover the open chamber.
24. The case of claim 21 further comprising a cradling structure,
within the chamber, constructed to hold the medication device
securely in a predetermined position during transport of the case.
Description
RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 09/853,501, filed May 11, 2001 and
incorporated herein by reference. This application also claims
priority from U.S. provisional application No. 60/203,880, filed
May 12, 2000 and incorporated herein by reference.
TECHNICAL FIELD
[0002] This invention relates to cases for medication delivery
devices, such as injection devices, e.g., auto-injectors and
syringes, and vials.
BACKGROUND
[0003] Certain individuals are highly allergic to foods, including
peanuts, other nuts, wheat, milk and shellfish. Others are highly
allergic to the stings of insects, such as bees and wasps, to latex
and/or to medications. When allergic patients are exposed to these
allergens, a severe reaction may occur (anaphylaxis) which may be
life-threatening if not treated immediately.
[0004] Epinephrine is generally used to treat an allergic patient
at the onset of an anaphylactic reaction. Epinephrine quickly
relieves bronchial swelling, constricts blood vessels, relaxes
smooth muscles in the lungs, stimulates the heartbeat, and acts to
reverse swelling, thus allowing the patient to function until
further treatment can be obtained.
[0005] Because exposure is unpredictable, the reaction can occur
quickly, and the patient may not be near medical help at the time
of exposure, patients who are subject to severe anaphylactic
reactions must carry epinephrine at all times. It is also necessary
that the patient be able to self-administer the epinephrine while
experiencing an allergic reaction. To address this need,
epinephrine is generally prescribed in an auto-injector, e.g., a
device commercially available under the tradename "EpiPen". The
auto-injector has a spring-activated, concealed needle that, when
triggered, springs forward to deliver a dose of epinephrine.
[0006] While epinephrine auto-injectors are life-saving devices
when properly cared for and used, a number of safety precautions
should be observed with these devices.
[0007] It is important that the auto-injector be used only for
intramuscular (rather than intravenous) injection. Currently,
manufacturers generally instruct that the auto-injector be used
only on the patient's thigh. Injection of epinephrine into other
areas can be dangerous. For example, injection into an extremity,
such as a hand or foot, can shut off blood supply to that area,
resulting in potential damage to the extremity. Vascular injection
can also be potentially dangerous because systemic delivery of the
epinephrine may cause complications in some patients due to a sharp
rise in blood pressure produced by the epinephrine.
[0008] Jostling and bumping of the auto-injector while the patient
is carrying the auto-injector has been known to cause accidental
triggering of the spring mechanism. Accidental triggering of the
auto-injector can result in injury to the patient or a caregiver or
bystander. Also, accidental triggering may exhaust the epinephrine
in the auto-injector, so that the epinephrine is not available when
needed during an anaphylactic reaction.
[0009] The patient may suffer extreme illness and even death if the
auto-injector is not in useable condition when it is needed. For
example, the patient may not be able to self-inject the epinephrine
if the spring-activation mechanism has been damaged by jostling or
impact of the auto-injector during storage and transport by the
patient.
[0010] The patient is also in danger if the medicine contained in
the injector has deteriorated. Epinephrine is heat and
light-sensitive, and as a result if the auto-injector is exposed to
direct sunlight or extreme heat the epinephrine may oxidize,
potentially rendering it ineffective. Epinephrine turns brown when
oxidized, so auto-injectors are typically provided with a window to
allow the patient to regularly inspect the color of the
medication.
[0011] Thus, it is important that the auto-injector be stored and
carried in a case that protects the auto-injector from accidental
triggering, damage due to jostling or impact, and exposure to
light. It is also crucial that the patient or a caregiver
(potentially a small child or elderly family member) be able to
remove the auto-injector from the case easily and quickly in a
crisis situation.
[0012] The Epi-Pen auto-injector is generally supplied by the
manufacturer in a thin plastic tube. This tube provides some
protection from light, but does not cushion the auto-injector to
protect it from jostling or impact. Accessory cases are available,
but many of these cases are not puncture proof, may not be easily
openable in a crisis situation, and/or do not adequately protect
the auto-injector from jostling or impact. It may also be difficult
to fit prescription or medical information into some accessory
cases.
[0013] In some cases, a single dose of epinephrine may not be
sufficient to treat a patient, for example if the patient is
suffering from extremely severe anaphlaxis. Thus, some highly
allergic patients may need to carry more than one auto-injector.
Doing so can also serve as a precaution if one of the
auto-injectors proves to be in an unusable condition, or is not
properly administered to the patient.
[0014] After an auto-injector has been used, the needle of the
injector remains exposed, presenting both a danger to persons
handling the expended auto-injector and a bio-hazard disposal
problem. After using an auto-injector, a patient is generally
directed to transport the used apparatus to the emergency room or
physician's office such that medical personnel can determine the
amount of medication that the patient received during usage of the
device. Transport of the apparatus with an exposed needle can prove
cumbersome and dangerous.
[0015] It is recommended that persons in need of auto-injectors
carry at least two auto-injectors with them at all times for double
life-saving protection. If one auto-injector fails, a back-up
device is immediately available for application. In addition, the
medication injected into the patient from a typical auto-injector
may only last for a short period of time, often up to 15 minutes,
and an additional dose of medication may need to be administered
thereafter until a patient can reach a medical treatment facility.
It is therefore desirable to have a mechanism whereby two
auto-injector cases may be attached together for convenient
transport.
[0016] Many auto-injectors are provided to the consumer as packaged
within a thin plastic tube, usually amber in color, with a plastic,
friction-fit end-cap closure. In some instances, a consumer or
manufacturer may not desire to remove the auto-injector from the
original tube in which it is packaged, but the consumer may still
want the benefits of a protective carrying case.
SUMMARY
[0017] The present invention features cases for medical injection
devices, e.g., auto-injectors, which protect the injection device
from damage and protect the device and the patient from accidental
triggering of the auto-injection mechanism. These cases also allow
the patient or a caregiver to easily and quickly access the device
in an emergency situation.
[0018] In one aspect, the invention features a case for a
medication delivery device including (a) a container body defining
an open chamber constructed to receive the medication delivery
device; (b) a lid constructed to cover the open chamber; and (c) a
cradling structure, within the chamber, constructed to hold the
medication device securely in a predetermined position during
transport of the case.
[0019] In another aspect, the invention features a case for a
medication delivery device including (a) a container body defining
an open chamber constructed to receive the medication delivery
device; (b) a lid constructed to cover the open chamber; and (c) a
latch constructed to maintain the lid in a closed position and to
provide a double-latching function. The latch includes (i) a latch
member, the latch member including a latch touch fastener and the
container body including a cooperating body touch fastener
constructed to engage the latch touch fastener when the latch
member is closed, (ii) a latch hinge joining the latch member to
the lid, the hinge member being constructed to allow the lid to
stay open without being held open, and (iii) a member constructed
to engage a portion of the container body in an interference
fit.
[0020] In a further aspect, the invention features a case for a
medication delivery device including (a) a container body defining
an open chamber constructed to receive the medication delivery
device; and (b) an encapsulating member, disposed at an end of the
open chamber, defining a receptacle constructed to receive an end
of the medication delivery device.
[0021] Some implementations include one or more of the following
features. The receptacle includes a portion for receiving a needle.
The needle-receiving portion includes a foam and a hard,
puncture-proof shell surrounding the foam. The receptacle includes
a portion for receiving a proximal end of the medication delivery
device, and preventing force from being applied to the proximal end
during storage of the medication delivery device in the case. The
receptacle is constructed to pivot between a first position in
which the receptacle is within the chamber and its long axis is
parallel to a long axis of the case, and a second position, in
which at least a portion of the receptacle extends out of the
chamber. The receptacle may be constructed to pivot through an
angle of about 90 degrees.
[0022] In yet another aspect, the invention features a case for a
medication delivery device including a container body defining an
open chamber constructed to receive the medication delivery device,
the container body including a connecting device, for connecting
the container body to another, similar container body, and a
receiving portion, for receiving a corresponding connecting device
of another case.
[0023] Some implementations may include one or more of the
following features. The cradling structure includes a cradle having
a curved surface. The curved surface has a curvature that
substantially corresponds to the curvature of a curved portion of
the medication delivery device. The cradling structure further
includes a foam layer covering at least a portion of the curved
surface of the cradle. The foam layer has a thickness of from about
1 to 3 mm. The cradling structure further includes a cradle guide.
The cradling structure is constructed so that the medication
delivery device press-fits into the cradling structure. The
cradling structure is constructed so that the medication delivery
device will not fall out of the cradling structure when the lid is
open and the open chamber is inverted. The cradle guide is
constructed to position the medication delivery device in a
predetermined location within the open chamber. The latch member
includes a latch touch fastener and the container body includes a
cooperating body touch fastener constructed to engage the latch
touch fastener when the latch member is closed. The touch fasteners
include elements of a hook and loop type fastener. The latch
includes a member constructed to engage a portion of the container
body in an interference fit. The medication delivery device
includes an auto-injector. The container body is puncture-proof.
The container body has a wall thickness of from about 1 to 4 mm.
The container body includes ABS plastic. The case further includes
needle ribs disposed within the chamber and constructed to receive
a needle portion of the medical delivery device.
[0024] Among the advantages of the invention, the cases are very
easy to open, even by individuals with compromised dexterity, e.g.,
an elderly person, small child, or patient suffering from an
allergic reaction. When the case has been opened, the injection
device will not fall out of the case, and yet is easily removed by
the user. This feature reduces the risk that a user will have to
pick up a dropped injection device or fumble around during a
crisis.
[0025] While the case is easy to open, it also fastens securely to
resist inadvertent opening, and thus prevent loss of or damage to
the injection device, and to prevent accidental triggering if the
device is an auto-injector.
[0026] The cases include a cushioned cradling system, which is
constructed to prevent the device from falling out, as discussed
above, and to prevent damage to the injection device from jostling
or impact during storage and transport. In some implementations,
the cushioning is white, to allow the patient to more easily
determine whether the solution in the injection device has become
discolored, e.g., due to oxidation.
[0027] The cases are rigid and puncture-proof, i.e., will prevent a
needle from puncturing through the case to its outer surface,
protecting the patient and others from puncture wounds. The cases
are also lightweight and compact, allowing the case to be easily
carried at all times.
[0028] In some implementations, the cases are designed to allow the
patient to conveniently carry other medication, e.g., antihistamine
tablets, more than one injection device, a prescription for the
injection device, and important medical information.
[0029] In some implementations, the case includes a `sharps
container` wherein the exposed needle portion of the auto-injector
is inserted into an inner core of dense foam that encloses the
needle end completely. The inner foam core is encapsulated within a
hard plastic outer shell for further protection of the exposed
needle. The "sharps container" feature both safely holds an unused
auto-injector, and facilitates safe handling and proper disposal of
a used auto-injector. A removable label may be provided to
immediately identify the used auto-injector as hazardous material.
The label may be applied around the outside of the case creating a
seal and preventing unnecessary opening and exposure of a case
containing hazardous material.
[0030] In some implementations of this invention, two cases can be
removably connected in order to allow the consumer flexibility of
carrying one or two devises. The connecting mechanism is designed
to connect the cases from bottom to bottom, thus ensuring access to
the auto-injectors housed inside the cases through the top lid of
either case. The connecting mechanism may be an integral design
that does not require external parts for implementation, or may use
an external connecting part.
[0031] In some implementations, an interior portion of the case may
include a cradle that is specifically designed to hold an
auto-injector that is contained within its manufacturer's
packaging. The cradle is dimensioned to accommodate the packaging,
e.g., a thin-walled plastic tube. The cradle may include a foam
layer, or the foam layer may be omitted. The case length may also
be modified to accommodate the tube. The case may de designed to
hold one or more auto-injectors within the packaging tube.
[0032] Other features and advantages of the invention will be
apparent from the description and drawings, and from the
claims.
DESCRIPTION OF DRAWINGS
[0033] FIG. 1 is a perspective view of an auto-injector case
according to one embodiment of the invention. FIG. 1A is a
perspective view of the auto-injector case in an open position.
FIG. 1B is a perspective view of the open auto-injector case with
an auto-injector inside.
[0034] FIG. 2 is a front plan view, and FIG. 2A is a side plan view
of the auto-injector case of FIG. 1.
[0035] FIG. 3 is a top sectional view of the auto-injector case of
FIG. 1 taken along line 3-3 in FIG. 2.
[0036] FIG. 4 is a sectional view of the auto-injector case of FIG.
1 taken along line 4-4 in FIG. 3.
[0037] FIG. 5 is a sectional view of the auto-injector case of FIG.
1 taken along line 5-5 in FIG. 4.
[0038] FIG. 6 is a sectional view of the auto-injector case of FIG.
1 taken along line 6-6 in FIG. 4, showing the latch in an open
position.
[0039] FIG. 7 is a sectional view of the auto-injector case of FIG.
1 taken along line 7-7 in FIG. 4, with a used injector pin in the
case.
[0040] FIG. 8 is a sectional view of the auto-injector case of FIG.
1 taken along line 8-8 in FIG. 3, with a used injector pin in the
case.
[0041] FIG. 9 is a top plan view of the auto-injector case of FIG.
1 with the sliders closed.
[0042] FIG. 10 is a top plan view of the auto-injector case of FIG.
1 with the sliders open.
[0043] FIG. 11 is a bottom plan view of the auto-injector case of
FIG. 1 with a belt clip in place.
[0044] FIG. 12 is a bottom plan view of the auto-injector case of
FIG. 1 with the belt clip omitted.
[0045] FIGS. 13 and 13A are examples of labels containing a
patient's medical information.
[0046] FIG. 14 is a top view with the lid partially broken away,
and FIG. 15 is a cross-sectional view of an auto-injector case for
carrying two auto-injectors.
[0047] FIG. 16 depicts a cross section of the interior of an
auto-injector case with an un-used auto-injector resting inside the
un-used needle encapsulator.
[0048] FIG. 17 depicts a magnified view of the needle end of the
auto-injector fully inserted into the needle encapsulator.
[0049] FIG. 18 depicts the un-used auto-injector pivoting up to
allow the un-used auto-injector to be removed from the case and
encapsulator.
[0050] FIG. 19 shows a magnified partial view of the exposed needle
of the used auto-injector inserted into the dense foam core of the
encapsulator.
[0051] FIG. 20 shows the used auto-injector returned to position in
the foam lined cradle.
[0052] FIG. 21 shows the bio-hazard label. FIGS. 21A and 21B are,
respectively, side and top views of the biohazard label of FIG. 21
applied around the outside of an auto-injector case containing an
ejected needle.
[0053] FIG. 22a shows a connector clip that is permanently attached
to one bottom end of a case, in a stored position. FIG. 22b shows
the connector clip rotated out of the stored position and into
position to connect to a second case.
[0054] FIG. 23 shows a cross-section of two cases with connector
clips flipped out and in ready position to be clipped together.
[0055] FIG. 24 shows a cross-section of two cases that have been
clipped together.
[0056] FIG. 25 shows an interior view of a case holding two
auto-injectors housed within their respective plastic tube
packaging. In this embodiment, the foam lining has been omitted
from the cradle. FIG. 25A is a side view of the plastic tube
packaging.
DETAILED DESCRIPTION
[0057] Referring to FIGS. 1-1B, an auto-injector case 20 includes a
container body 25 that is constructed to receive an auto-injector
10 (FIG. 1B) in a cradling engagement, as will be discussed below.
The case 20 also includes a lid 21 that securely engages the
container body 25. The lid is mounted on the container using a pair
of hinges 30 that are constructed to maintain the lid in a desired
position after the lid has been opened by a user (i.e., to prevent
the lid from self-closing if it is not held open). This feature of
the hinges is generally provided by using a hinge with a tight
friction fit. This feature facilitates removal of the auto-injector
10 from the case 20, and is particularly helpful for users who have
a low level of dexterity.
[0058] The case 20 also includes a secure, yet easily openable,
latch 32. Latch 32 provides a double latching function, securing
the lid both by an interference fit with the rim of the container
25 and by engagement of a touch fastener element, as will be
discussed in detail below.
[0059] The case 20 should generally be able to withstand the high
impact force that may occur if the auto-injector is accidentally
triggered when it is inside the case. The lid 21 and container body
25 are formed of a rigid, high-strength plastic, for example ABS,
so that puncture-proofness can be provided with a relatively thin
wall thickness. However, if desired, other plastics may be used,
e.g., polyethylene, polypropylene, and other moldable
thermoplastics. If ABS or a similar plastic is used, the wall
thickness is generally from about 1 to 4 mm, more preferably about
1.0 to 2.5 mm. If other plastics are used, the wall thickness is
selected to provide puncture-proofness. Puncture-proofness is
further enhanced by an arcuate rib 90 that extends downwardly from
the lid 21 in front of the needle end of the auto-injector 10 when
the case is closed. Arcuate rib 90 is discussed further below.
[0060] Lid 21 includes a hinge portion 16, which cooperates with a
corresponding hinge portion 18 on latch member 19 to provide a
latch hinge 17. The latch hinge 17 is constructed to hold the latch
member 19 in a fixed position when the latch member 19 is fully
extended. This feature keeps the latch member 19 from flopping down
when the user is trying to open the lid, further enhancing the ease
with which the lid can be opened. When the latch member 19 is in
its fixed position it also serves as a handle which can be used to
lift the lid 21.
[0061] Referring to FIG. 6, latch member 19 includes a touch
fastener strip 34 on its inner surface 64. Touch fastener strip 34
is positioned for engagement with a cooperating touch fastener
strip 35 on the outer surface 66 of container body 25. Touch
fastener strips 34 and 35 may be, for example, male and female
portions of a hook-and-loop fastener, for example fasteners
commercially available under the tradename VELCRO. The engagement
of the touch fastener holds the latch member securely in place
against the outer surface of the container body 25, while allowing
the latch member to be easily disengaged by a user.
[0062] As shown in FIG. 1A, hinge portion 16 includes a groove 68
that is constructed to engage ridge 70 on rim 72 of the container
body 25 in an interference fit to further secure the lid in a
closed position. This provides a back-up latching mechanism, in the
event that the touch fastener strips 34, 35 do not engage when the
user closes the lid, or in the unlikely event that the touch
fastener becomes accidentally disengaged. The engagement of ridge
70 in groove 68 is secure against accidental disengagement, but
easily snaps open in response to a user applying upward pressure to
the latch member 19. This snap fit is further enhanced by an
interference engagement between rim 74 of lid 21 and rim 72 of the
container body 25.
[0063] As noted above, the container body 25 includes a cradling
structure that prevents jostling and bumping of the auto-injector
when it is carried by the patient. Referring to FIGS. 1A and 6, the
inner surface of container body 25 includes a cradle 39 that has a
curved surface with a curvature that conforms to the curvature of
the auto-injector. For an EpiPen auto-injector, a suitable radius
of curvature R is about 8 to 10 mm, e.g., about 9 mm.
[0064] A foam pad 42 is mounted on the curved surface of the cradle
39, to provide a snug, resilient engagement between the
auto-injector and the cradle 39. Preferably, the foam pad 42 and
cradle 39 are dimensioned so that the auto-injector press-fits into
the cradle in response to gentle pressure by the user, or in
response to the pressure that is applied to the auto-injector when
the lid is closed, if the user has not already pressed the
auto-injector into the cradle.
[0065] The foam pad 42 cushions the auto-injector against impact,
further reducing the likelihood of accidental triggering. By
resiliently engaging the auto-injector, the foam pad 42 also
prevents the auto-injector from falling out of the container when
the lid is opened. Preferably, the auto-injector fits sufficiently
snugly into the cradle 39 so that the open case 20 (FIG. 1B) can be
completely inverted without the auto-injector falling out. By
reducing the likelihood that the auto-injector will be dropped when
the case is open, this feature also reduces the danger that
precious treatment time will be wasted while the patient or a
caregiver struggles to find a dropped auto-injector. Similarly,
this feature reduces the likelihood of accidental triggering, which
may occur if an auto-injector is dropped.
[0066] Suitable foams include closed cell, low to medium density
foams. Suitable foams have sufficient compressibility to provide
the cushioning and resilient engagement features discussed above.
Suitable foams include polyethylene foams. Preferably the foam does
not contain any latex, to avoid allergic reactions. The radius of
curvature of the cradle can be adjusted based on the density of the
foam to provide a desired degree of resilient engagement
(generally, lower density foams will require a smaller radius
cradle).
[0067] The foam pad is sufficiently thick to provide cushioning and
resilient engagement, but sufficiently thin so that the
auto-injector can be readily removed from the cradle by the patient
or a caregiver. Preferably, the foam pad is from about 1 to 3 mm
thick when uncompressed, more preferably about 1.25 to 1.75 mm
thick.
[0068] Preferably, the foam pad is white, so that the patient or
caregiver can easily observe whether the liquid in the
auto-injector is clear, as it should be for an epinephrine
injector, or whether the liquid is colored, indicating oxidation
and/or deterioration.
[0069] In some applications, it may be useful to provide additional
foam padding on the inside surface of lid 21. If such padding is
used, it should be dimensioned and positioned so that the lid will
close properly.
[0070] Referring to FIGS. 1A, 1B and 4, the container body 25 also
includes a cradle guide 76 that extends generally perpendicular to
the longitudinal axis of the auto-injector 10 when the
auto-injector is in place (FIG. 1B). Cradle guide 76 includes a
curved opening 78 through which the smaller diameter, forward
portion 80 of the auto-injector can extend. Curved edge 82 of
cradle guide 76 acts as a stop, properly positioning the larger
diameter portion 84 of the auto-injector in the cradle 39 for easy
removal of the auto-injector. The cradle guide positions the
auto-injector so that there is a gap 86 on each end of the
auto-injector (FIG. 1B), allowing a user to easily slip a fingertip
into the gap to lever the end of the auto-injector out of the
cradle 39.
[0071] After the auto-injector has been triggered, whether
intentionally or unintentionally, the needle is exposed and remains
exposed, thus creating a danger of puncture wounds. If the
auto-injector has been triggered intentionally, it is necessary for
the patient to bring the auto-injector to the treating physician so
that the physician will know how much epinephrine has been taken.
As shown in FIGS. 7 and 8, the container body includes needle ribs
40, which enclose the needle 88 during transport, providing a safe,
puncture-proof way to carry the used auto-injector to the hospital
or treating physician. The needle ribs 40 also reduce the risk of
accidentally stabbing a finger when the used auto-injector is
removed from the case, by preventing the user from grasping the
needle by the tip during removal. Needle ribs 40 are preferably
substantially flat plastic members, integrally molded with the
container body 25 of the same puncture-proof material. Preferably
the ribs are from about 1.0 to 2.5 mm thick.
[0072] The lid 21 includes an arcuate rib 90, extending downwardly
from the inner surface of the lid, which is positioned in front of
the needle end of the auto-injector when the lid is closed. Arcuate
rib 90 enhances the puncture-proofness of the case 20, because in
the event of accidental triggering of the auto-injector the arcuate
rib 90 will either push the needle 88 down between the ribs, or
force it partially back into the auto-injector, depending upon the
angle at which the needle is discharged. The arcuate rib 90 is
positioned so that it will not force the needle fully back into the
auto-injector, so that it will be possible for the user to observe
that accidental triggering has occurred. If the arcuate rib is
formed of ABS or a plastic with similar mechanical properties, the
arcuate rib is preferably about 1 to 3 mm thick, e.g., about 2 mm.
The arcuate rib is mounted on a support that is positioned directly
in front of the needle of the auto-injector, to further enhance
puncture-proofness. The support preferably has a thickness of from
about 1 to 3 mm.
[0073] In some cases, a patient may have an allergic reaction that
is not severe enough to warrant injection, and yet requires
treatment, e.g., with an antihistamine such as BENADRYL
antihistamine. To allow the patient to keep all of his or her
emergency allergy medication together in one place, the container
body 25 also includes medication slots 43 for holding two
push-through packets containing antihistamine tablets.
[0074] Some emergency medical personnel are reluctant to administer
an epinephrine injection without a prescription. To avoid this
problem, the container body 25 is preferably sized to permit the
patient to carry a folded prescription in prescription storage
location 49.
[0075] To allow the patient to provide medical history information
to a caregiver in an emergency, while keeping the information
private at other times, the case 20 includes sliders 29 which are
movably mounted on lid 21 to slide along tracks 37 (FIGS. 9 and
10). In the open position, shown in FIG. 10, the sliders 29 reveal
a medical history panel 36. When the sliders are in the closed
position, shown in FIG. 9, the information on the medical history
panel 36 remains private.
[0076] A label 50, e.g., as shown in FIG. 13A, can be mounted on
the medical history panel, giving the patient's medical and
emergency information 52, e.g., name, phone number, allergies, and
doctor's name and phone number.
[0077] A more detailed label 50' that may be used is shown in FIG.
13. This label includes medical information symbols 51, a name
plate 52', areas that can be checked off or circled to indicate
foods or materials to which the patient is allergic, e.g., bee
sting (53), peanuts (54) or penicillin (55), and blank areas 60 to
allow the patient to fill in other foods/materials that are not
listed. Label 50' also includes a box 56 to indicate the expiration
date of the auto-injector, identifies the auto-injector as an adult
dosage (57) or junior dosage (58), and notifies a caregiver that a
prescription is located in the case (59).
[0078] Labels 50, 50' are preferably moisture resistant, and users
are instructed to use an indelible marker to fill in the
information.
[0079] The case 20 may include various accessories to enable a
patient to have it handy at all times.
[0080] For example, a magnet (not shown) can be provided, e.g., on
the bottom outer surface of the container body, to allow the case
20 to be removably mounted on a refrigerator, filing cabinet or
other convenient metal area.
[0081] Also, as shown in FIGS. 4, 8 and 11, the case 20 may include
a removable belt clip 44. Belt clip 44 may be of any suitable
material, e.g., plastic or metal, and is removably inserted into
belt clip hole 46 by compressing the belt clip prongs 45 (FIG. 11).
Belt clip hole 46 is covered with a cap 47 (FIG. 12) when the belt
clip is not in use.
[0082] The case 20 may also be provided with a self-adhering strap
(not shown), e.g., of a touch fastener material such as VELCRO
fastener material. The self-adhering strap can be threaded through
the belt clip hole 46 and attached to itself to form a loop. A
hook, e.g., a snap-hook, can be attached to the loop to allow case
20 to be hung from a knapsack, wall hook or other location. The
self-adhering strap can also be looped through the belt clip holes
of two cases, to hold the cases together, e.g., for patients who
carry a second auto-injector as a back-up or for caregivers who are
responsible for the storage of injectors for more than one
user.
[0083] Other embodiments are within the scope of the following
claims.
[0084] For example, while the discussion above has focused on cases
for epinephrine auto-injectors, the cases described above are
suitable for use with auto-injectors containing other types of
medication, e.g., antidotes for chemical poisoning such as are used
in military applications. Also, while the cases described above are
particularly suitable for use with auto-injectors, they may also be
used with other types of medication delivery devices, for example,
syringes containing medications such as insulin or morphine, and
fragile medication-containing vials. If the case is used with a
medication that must be kept cold, e.g., insulin, space can be
provided in the case for a tiny cold pack
[0085] Moreover, while the latch in the implementation described
above is secured using a touch fastener, any desired type of
fastener may be used, as long as the fastener is relatively secure
and can be easily disengaged by a user. Other suitable fasteners
include snaps, magnets and pressure sensitive adhesives.
[0086] Additionally, the sliders discussed above may be replaced by
a flap or other structure that allows the patient information to be
concealed, or may be omitted and the patient information provided
inside the case.
[0087] While the case described above is sized to hold a single
auto-injector, in other implementations the case is sized to hold
two auto-injectors side by side. In these implementations, the case
includes two cradles and two sets of needle ribs, e.g., as shown in
FIGS. 14 and 15.
[0088] As depicted in FIG. 16, a needle encapsulator (104) may be
built into the interior of the case at the end intended to
accommodate the needle end of the auto-injector (103). The needle
encapsulator generally consists of a rigid tube-shaped outer shell
composed of a hard plastic or other suitable material that has a
hollow opening on one end (101) and is tapered at the other end
(102). Inside the tapered end (102) of the encapsulator (104) is a
dense foam inner core (105). The un-used auto-injector's needle end
(103) rests inside the hollow end (101) of the encapsulator inside
the case (108). The needle end (103) fits loosely into the hollow
end (101) of the encapsulator ensuring easy remove of the unused
injector. The foam layer (121) on the inside of the cradle
frictionally fits the body of the auto-injector (107) preventing it
from jostling and slipping out of the case.
[0089] The hollow end of the encapsulator (101) shown in FIG. 17 is
sized at a specific length to allow space (122) between the needle
end (103) of the auto-injector and the flat inside surface (123) of
the encapsulator (104). The space (122) is generally greater than
1.0 mm. External force applied to the needle end (103) of the
auto-injector is required to discharge the needle and medicine
inside the case. The hollow end (101) of the encapsulator (104) is
sized to bottom-out on the shoulder of the auto-injector (124)
preventing any force from being applied to the needle end (103) of
the auto-injector (107), thereby preventing accidental
discharge.
[0090] FIG. 18 shows the encapsulator (104) as it pivots about a
pivoting head (110), such as on a pivoting post or on a pivoting
ball, such that the encapsulator with unused auto-injector rotates
easily upward in a singular plane perpendicular to the bottom of
the case when a force is applied at the grey end cap end (111) of
the auto-injector by a person removing the auto-injector (107) from
the case (108). Once the encapsulator (104) with un-used
auto-injector (107) is pivoted upward, the un-used auto-injector
(107) easily slides out of the encapsulator (104). The preferred
range of pivot of the auto-injector (107) to allow easy insertion
into and removal from the encapsulator (104) is from 0 degrees to
90 degrees from the inside surface of the case.
[0091] Referring to FIG. 19, the needle (112) of the used
auto-injector (120) shown in FIG. 19 remains permanently exposed
and attached to the auto-injector (120) after injection. The
exposed needle (112), contaminated with medicine and blood residue,
is inserted back into the needle encapsulator (104) where the
needle is removably imbedded into the dense foam core (105) at the
tapered end (110) of the encapsulator (104). The used auto-injector
(120) is then pivoted back down into the foam-lined cradle (121) of
the case for safe transport (FIG. 20).
[0092] In the embodiment shown in FIGS. 16-20, the length of the
case is generally about 175.0 mm, to allow room for the needle
encapsulator (104). Advantageously, the encapsulator (104) also
acts as a puncture-proof feature. In case of malfunction of an
auto-injector stored inside the case, the fully ejected needle
(112) is completely encased and cannot extend through the wall at
the pivoting end of the needle encapsulator (106) or through the
outside wall of the case.
[0093] A label indicating `Bio-Hazardous Material` (126), shown in
FIG. 21, may be included with each case and may be applied by the
consumer after the auto-injector is dispensed and returned to the
case for safe handling. The Bio-Hazard label (126) is wrapped
around the outside surface of a closed case (127) containing a
dispensed auto-injector, as shown in FIGS. 21A and 21B. The label
(126) is positioned in such a way around the short circumference of
the case that it seals the case shut and prevents the case from
being opened without purposefully breaking the label.
[0094] In order to connect two cases together, a connecting device,
or `connector clip` (114), shown in FIGS. 22a and 22b, is stored
within a recess (113) at one end of the case located on the bottom
surface, preferably at the needle end of the case. The connecting
device (114) generally consists of hard plastic or other suitable
material, and is shaped as a rectangular clip. The connecting
device (114) is designed with an attached end (128) that is
permanently connected to the case with a metal pin or other
suitable method. The free end (129) of the connecting device is
designed with an integral snapping mechanism and stores flush with
the bottom of the case.
[0095] FIG. 23 shows how to connect to cases together. The
connecting device (114) may be released from the exterior of the
case and extended out perpendicularly to the case. Once extended,
the connecting device (114) is inserted into a receiving slot (115)
located on the second case, preferably at the opposite end, or
non-needle tip end, of the case.
[0096] The receiving slot (115) may have a snap portion 116, to
allow the connecting device to snap securely into the receiving
slot (115). Because each case would have both a connecting device
(114) and a receiving slot (115) integrally attached to the case at
opposite ends, two cases may be clipped together by extending each
connecting device from each case and facing the cases opposite each
other, and by snapping each connecting device (114) into the
corresponding opposed receiving slot (115) as depicted in FIG. 24.
The bottom surfaces (130) of the cases are connected, providing
ample access for either case top to be unobstructively opened to
access either auto-injector contained inside. Once clipped
together, the cases may then be separated by applying a force to
the snap portion (116) of each connecting device perpendicular to
the length of the connecting device (114) to release the snap
mechanism.
[0097] FIG. 25 shows an interior view of the case (131) holding two
auto-injectors (117) housed within their plastic tube packaging
(118) (FIG. 25A). In this embodiment, the foam linings have been
omitted from the cradles. The length of the case (119) is enlarged
to accommodate the manufacturer's tube and is generally about 172.0
mm in length.
* * * * *