Special receptacle or package – For a tool – Body treatment
Reexamination Certificate
2001-05-11
2003-07-22
Fidei, David T. (Department: 3728)
Special receptacle or package
For a tool
Body treatment
C206S366000, C206S523000
Reexamination Certificate
active
06595362
ABSTRACT:
TECHNICAL FIELD
This invention relates to cases for medication delivery devices, such as injection devices, e.g., auto-injectors and syringes, and vials.
BACKGROUND
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
SUMMARY
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.
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.
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 foam layer is white. 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 case further includes a hinge joining the lid to the container body. The hinge has a sufficiently tight friction fit to allow the lid to stay open without being held open. The case further comprises a latch constructed to secure the lid in a closed position. The latch is constructed to provide a double-latching function. The latch includes a latch member, and a latch hinge joining the latch member to the lid. The latch hinge is constructed to allow the lid to stay open without being held open. 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. The case further includes a medical history panel, and a cover constructed to conceal the medical history panel. The case further includes a belt clip mounted on the container body or lid.
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 del
Lussier Sherin
Penney Melinda
Tomellini Dalita R.
Fidei David T.
Lindon Products Inc.
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