Container for Transporting Temperature Controlled Items

Abstract

A reusable container for transporting temperature controlled items, which includes an outer case including a lid, and an insulating layer substantially inside the outer case and the lid. A generally rigid well is located inside the insulating later. At least one cooling element is provided, which is capable of maintaining temperature within a prescribed temperature range for predetermined periods of time, the cooling element being disposed within the well and at least partially defining a receptacle area. A caddy can be located in the receptacle area, at least partially surrounded by the cooling element, and is designed to accommodate at least one item to be transported. The cooling element may include a phase change material sealed within a plastic surround, and is designed to be separately removable and freezable prior to use. Temperature logging and / or location logging devices may be included.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application is a Continuation-In-Part to U.S. patent application Ser. No. 11 / 333,194 filed Jan. 17, 2006, which was a Continuation-In-Part to U.S. patent application Ser. No. 11 / 281,548 filed Nov. 17, 2005 which claims priority to U.S. Provisional Patent Application No. 60 / 681,769 filed May 17, 2005. The present application also claims priority to U.S. Provisional Patent Application No. 60 / 681,774 filed May 17, 2005, U.S. Provisional Patent Application No. 60 / 681,770 filed May 17, 2005 and U.S. Provisional Patent Application No. 60 / 682,318 filed May 18, 2005. The entire disclosures of these earlier applications are incorporated herein by reference.FIELD OF THE INVENTION [0002] The invention relates generally to a container for transporting temperature controlled items such as one or more of biological material, biologics, pharmaceuticals, chemicals and food products at a required temperature range. BACKGROUND OF THE INVENTIO...

AI Technical Summary

Benefits of technology

[0017] The cooling element is an important feature of the container in accordance with the present invention. The cooling element can include four modular units shaped and sized to securely fit the top, bottom and sides of the inner perimeter of the well and are adapted to form a receptacle area for housing an inner caddy. Alternatively, the cooling element can be in one piece and can include a bottom, side walls and at least one top portion, wherein the top portion is hinged to the side walls. The cooling element is responsible for keeping the inner caddy at the required temperature (for example, 1° C. to 6° C.), and is made from strong, durable and lightweight material, such as ABS plastic. A cooling material is disposed in all or part of the cooling elements and may include a phase change material. The cooling element is adapted, when frozen and conditioned, to maintain the required temperature for extended periods of time, i.e. 24+hours. The cooling elements can be frozen prior to each day's use in any standard or commercial freezer for up to 24 hours prior to each use. The cooling elements are stackable and provide for easy storage in a freezer. After removal from the freezer, the cooling elements can be conditioned prior to use and insertion into the container. The object of conditioning the cooling elements is to allow it to transition from the temperature of the freezer to a temperature proximal to the desired phase change temperature. This can be achieved simply by exposing the cooling elements to the ambient room temperature by placing it out on a counter (not in the insulated case), for approximately 30 to 60 minutes.

[0018] The container can include an inner caddy, which provides for a bottom portion connected to sidewalls, a front wall, a back wall and a middle divider. Lifting means can be provided for lifting and removing the inner caddy from the container. Lifting means may include a handle, strap, tab, or anything that can be grasped or is generally known and used by those skilled in the arts. In one arrangement, the walls include one or more top portions that are hinged. The top portions may form a lid which opens outwardly from the receptacle area. In another arrangement, the inner caddy opens from front to back providing access to its contents. The inner caddy is removable with cleaning vents, allowing for self-drainage and ease of cleaning. The inner caddy is conveniently sized such that it may be stored in a standard or commercial refrigerator with the item to be transported preloaded in the caddy until the item is ready for transport or use.

Problems solved by technology

Transporting biological material such as blood and blood products in a timely manner has always been a problem.

The coolers that have been used to cool biological and related materials have significant limitations.

For example, they do not address the need for documented temperature monitoring for blood products for transfusions that the Food and Drug Administration (FDA) requires as of 2004.

The FDA requires that blood and blood products taken out of storage and transported must be maintained at transport temperature range of 1° C. to 10° C. which compromises the time of acceptable use.

However, one of the limitations of this method of transportation is that wet ice is messy, often spills during transportation, and re-icing while in transit is sometimes challenging in remote areas.

Dry ice offers its own complications as it can be hazardous; for example, loose dry ice can inadvertently touch the blood or blood product, causing it to freeze the blood or blood product at the area of contact and damage the entire product.

Furthermore, if dry ice is placed in a non-vented container, it will explode, and so care must be taken to vent the container.

Concentrations of CO2 can also build up to harmful levels inside the container as the dry ice transforms to its gaseous form.

Additionally, dry ice is sometimes unavailable in certain parts of the world, and is difficult to handle as it can burn the skin of a user.

These factors only serve to further limit the ability to transport blood and blood products for prolonged periods.

However, gel packs are susceptible to leaks and can therefore be unreliable.

Additionally, it is difficult to maintain a consistent temperature within the entire blood or blood product with gel packs, since standard-sized gel packs are not customized and move around during shipment.

Another limitation is that the blood and blood products and other biological material, biologics or certain pharmaceuticals need to be maintained at the required temperature over prolonged periods when transported.

Conventional insulated shipping containers do not address this problem, which can be further complicated when the items are being transported internationally.

The transportation of platelet concentrates is particularly problematic, because of the need to keep such concentrates within a temperature range between 20° C. and 24° C. Such temperature ranges are very difficult to maintain using dry or wet ice, or gel packs, which tend to cool the product too much.

The resulting packages are bulky, and there is also no way to ensure that the temperature stays constant through different weather conditions (and varying ambient temperatures in hospitals and laboratories) that the package may be transported.

There are additionally problems with the transportation of various foodstuffs, such as prepared food, fish and seafood, and other perishables including poultry, meats, and dairy products, in that food safety and taste can be severely compromised if the food is not transported at a reduced temperature.

Images