Patent Application
20050269231
1. Field of the Invention
The invention relates to the field of containers for packaging devices. Specifically the invention relates to a container that can be employed to grasp and transfer a packaged device from the container to another location in order to minimize contamination of the device prior to use.
2. Description of the Related Technology
It is desirable to keep certain types of devices sterile or to minimize contamination of such devices until used. Exemplary devices can include probes, knives, scissors, cutters, applicators, implantation devices, catheters and other devices for which sterility or at least minimal contamination is required. Typically, these devices are sealed in a package and sterilized after sealing by treatment with radiation or gas. An exemplary package for this type of device consists of a thermoformed plastic blister tray provided with an airtight seal formed by a spun polyester sheet. Other packages are formed from two mating plastic trays that snap together with the device inside, the entire assembly being sealed in an air-tight pouch.
While such packages are effective for delivering the devices to the location of use in a substantially uncontaminated state, there is an additional need to minimize contamination of such devices that occurs during transfer of the device from the package to another location for use, thereby increasing the ease with which a device may be used. For example, during the course of surgery, it is often necessary to remove various instruments and devices from sterile packaging. Medical personnel are required to maintain an environment of sterility and need to be dressed accordingly. Gloves worn by medical personnel to maintain sterility often make it difficult to manipulate items in packaging. Current packaging methods and containers do not sufficiently address the need to maintain sterility and to provide ease of transport of the device upon opening the package. Specifically, current packages generally do not facilitate the transfer of the sterile contents of a package into a sterile field without contamination or damage to the contents by, for example, having to dump the contents onto a table for use.
For example, U.S. Pat. No. 5,842,567 to Rowe et al. discloses a quick release package for use with medical devices. The package is made of plastic. The package is constructed so that it is form fitted around a medical probe. The package has snaps for closing the package. The package is designed primarily for quick opening by pressing down on the edge of a tab. U.S. Pat. No. 5,178,282 to Williams discloses a modular surgical packaging system. The container allows the stored components to be sterilized.
U.S. Pat. No. 6,012,580 to Peters et al. discloses a package for medical implants. The package may be squeezed from the sides to release the medical device contained therein. This permits removal of the medical device without touching the device and risking contamination. However, the primary purpose of the finger holds used on the package is to provide a means for opening the package and not a means for gripping the device housed in the package using the package itself as a gripping means. This increases the risk of accidentally dropping the device and therefore still contaminating the device despite the release mechanism disclosed.
Therefore there remains a need in the field for a container that keeps packaged device sterile and permits the handler of the object to easily transfer the object from the container to its place of use, while minimizing potential contamination of the device.
There is also a need for packages which can be used to permit a non-sterile worker to transfer the sterile contents of the package into a sterile field without a significant risk of damage or contamination to the contents of the package.
Also, there is a need for packages which can be used to package and ship potentially hazardous devices which may include, for example, corrosive materials, poisonous materials, irritants and/or radioactive materials, in a safe manner and permit the end user to handle such hazardous devices with a minimum of contamination of the user by the device.
Accordingly, it is an object of certain embodiments of the invention to provide an improved container for packaging various types of devices. The present invention provides a container useful for both packaging a device and for transferring the device from the container to its place of use with a minimum amount of contamination of the device by the user, or with a minimum amount of contamination of the user by the device.
A container is provided which has a first container portion and a second container portion. One portion of the container is provided with a grip that is graspable by a user's hand and a holder for holding the device using that same portion of the container to permit that portion of the container to be gripped and used to transfer the device from the container to another location without having to directly contact the device. The portion of the container used for transferring the device serves as a barrier between the device and the user to minimize contamination of the device by the user or to minimize contamination of the user by the device.
In a second aspect, the present invention provides a method for shipping and handling packaged devices that minimizes contamination of the devices during shipping and transfer of the device out of the shipping container for use. In the method, a container is provided having first and second container portions. One portion of the container is provided with a grip that is graspable by a user's hand and a holder for holding the device using that portion of the container. In the method, the device is placed into the container, and the container is sealed and sterilized. Then, upon opening the container, the user grasps the grip that forms part of one portion of the container and removes the device from the container using that portion of the container as a barrier between the user and the device. The device is held by the portion of the container provided with the grip to thereby permit removal of the device from the container without directly contacting the device.
For a better understanding of the invention, its advantages, and the objects obtained by its use, reference should be made to the drawings which form a further part hereof, and to the accompanying descriptive matter, in which there is illustrated and described preferred embodiments of the invention.
Referring now to the drawings, wherein like reference numerals designate corresponding structure throughout the several views,
Specifically, the container 10 of the present invention is particular useful for the packaging and shipping of sterile devices. The container 10 of the present invention permits the user of the sterile device to open the container, and deploy the sterile contents of the container with a minimal risk of damage or contamination to the contents of the container 10. In fact, a non-sterile worker can open the container 10 and deploy the sterile contents with a minimal risk of contamination and without risk of damage which can be caused by, for example, having to dump the contents of the container onto a table or other surface. Instead, the sterile contents of container 10 can be directly deployed, by a non-sterile worker, into a sterile field for immediate use in a sterile environment.
First container portion 11 is comprised of a bottom 8 two sides 6, a front 5 and a back 7 which together form a receptacle capable of receiving at least a portion of second container portion 12, as well as the packaged device therein. First container portion 11 includes a pair of corner indentations 14 in the corners between bottom 8, sides 6 and back 7 which form a pair of shoulders 16 inside of first container portion 11, as shown in
Second container portion 12 fits within first container portion 11 between front 5 and shoulders 16 to create a space in the area 15 of first container portion 11. The space in the area 15 of first container portion 11 is desirable in this embodiment of the invention since the packaged device is designed for attachment to an articulating arm. Thus, the space in area 15 provides room for an attachment portion of the packaged device to extend beyond the periphery of second container portion 12 when the packaged device is located in container 10. Due to this feature, the packaged device can be attached directly to the articulating arm while it is still held by second container portion 12 because the attachment portion of the packaged device extends sufficiently far out of second container portion 12 that it can be attached to an articulating arm without interference from second container portion 12.
Accordingly, in one aspect of the invention, second container portion 12 may be sized relative to the packaged device to permit a portion of the packaged device to extend beyond the periphery of second container portion 12 to facilitate interaction of the packaged device with another device without having to remove the packaged device from second container portion 12 or having to directly handle the packaged device. First container portion 11 may be sized appropriately to accommodate the portion of the packaged device that extends beyond the periphery of second container portion 12, as well as at least part, or all, of second container portion 12, as desired.
Shoulders 16, sides 6 and front 5 of first container portion 11 together limit the movement of second container portion 12 relative to first container portion 11, when second container portion 12 is inserted within first container portion 11. It is possible to size first and second container portions 11, 12 such that the walls of second container portion 12 abut with shoulders 16 when second container portion 12 is located within first container portion 11, but this is not necessary. Thus, it is also possible to leave some space between the walls of second container portion 12 and shoulders 16 to permit a certain amount of play between the first and second container portions 11, 12 when they are associated with one another. In general, it is desirable to minimize the amount of force required to separate first and second container portions 11, 12 to facilitate opening container 10. For this reason, it may be desirable to permit a certain amount of play between first and second container portions 11, 12 when they are associated with one another. Also, due to the nature of the packaged devices, it will generally be necessary to seal container 10, by, for example, shrink-wrapping container 10, or heat-sealing using a Tyvek® lid or pouch or other suitable closures or sealing materials. Raised portion 2 is the surface utilized during heat-sealing. As a result, the sealing means can also function to maintain the association of the first and second container portions 11, 12 thereby obviating the need for first and second container portions 11, 12 to be attached to one another. However, if it is desirable, first and second container portions 11, 12 can be attached to one another by, for example, a hinge, so long as it is possible to separate first and second container portions 11, 12 sufficiently to permit second container portion 12 to accomplish its function of transferring the packaged device from container 10 to another location.
Typically, container 10 is constructed of plastic material. The material of container 10 may be sterilizeable, particularly if the packaged device is a sterile device, such as a medical device. Container 10 is also preferably lightweight, and inexpensive to manufacture. First and second container portions 11, 12 may be constructed of the same or different materials. If the device to be shipped in container 10 is radioactive, for example, it may be desirable to construct all or a portion of container 10 from a radiation shielding material, or to include a radiation shielding material in all or a portion of one or both of first and second container portions 11, 12. Container 10 may be sterilized and subsequently sealed, by, for example, a flexible material such as a pliable film such as a polyolefin film, shrink-wrap material, Tyvek®, flexible sheet material, or other suitable material prior to shipping. Alternatively, the device located inside of container 10 may be sterilized and subsequently sealed by, for example, a flexible material such as a pliable film, e.g. polyolefin film, shrink-wrap material, Tyvek®, flexible sheet material, or other suitable material, prior to closing the device in container 10. Container 10 may be sealed for the purpose of maintaining a sterile environment within container 10 during storage and shipping, or for the purpose of containing potentially hazardous materials such as corrosives, irritants, poisons or radioactive materials inside container 10 during storage and shipping. Upon arrival at its destination the sealing material may be removed from container 10 in order to allow access to the contents of container 10.
First container portion 11 may include a peripheral flange 4 around all or a portion of the periphery of first container portion 11. Peripheral flange 4 can provide stability to container 10 when placed on a flat surface and may also be used to facilitate location of container 10 in a larger storage or shipping container designed for storage or shipment of a plurality of containers 10 at one time. Peripheral flange 4 may be provided with one or more protrusions 3 on the top surface thereof, which protrusions 3 can form part of a snap-fit or friction-fit engagement with another container or device, for example. Protrusions 3 can also be used to create a space between a lid, used to cover container 10, and container portion 11 to facilitate removal of the lid by permitting a person who is opening container 10 to get his/or her finger under the lid. Peripheral flange 4 may also include a raised portion 2 that extends around all or part of the periphery of first container portion 11 of container 10, and which is explained in greater detail below in reference to
Referring to
Referring to
Referring now to
It is not necessary to form shoulders 16 or central ridge 20 by the provision of indentations 14, 18, as in the present embodiment, but this type of structure has the advantage that it lends itself well to certain molding processes that facilitate production of container 10. Alternatively, first container portion 11 could be a circular or square container, or any other suitable shape, and include no indentations. In such a case, shoulders 16 and/or central ridge 20 could be provided, for example, by the location of additional structure within first container portion 11.
Referring to
In this case, the distal portion 240 of the ocular brachytherapy applicator 230 is to be used in sterile condition and thus it is desirable to ship distal portion 240 in container 10. Distal portion 240 has a generally cylindrical shape and thus central cylindrical trough 36 is provided with a generally cylindrical shape to accommodate this. Central cylindrical trough 36 also includes a pair of recesses 38 which appear as bulges 27 in the top view of second container portion 12 shown in
Central cylindrical trough 36 is one example of a holding structure that may take many different shapes, depending on the device to be packaged. The function of the holding structure is to hold the packaged device so that second container portion 12 may be grasped and used to transfer the packaged device from container 10 to another location without having to touch the packaged device directly. Thus, in certain embodiments, the holding structure may be designed to provide a snap-fit, form-fit or friction-fit with the packaged device. Alternatively, the holding structure may provide a close fit with the packaged device and the second container portion 12 may be fabricated from a flexible material which allows sufficient deformation of the holding structure, by application of force from the user's hand, to grasp and hold the packaged device in the holding structure. Other ways of releasably attaching the packaged device to the container 10 may also be employed. For example, a hook and loop attachment such as Velcro® or another similar attachment can be employed. Other possible holding structures include, for example, releasable clips, magnets, and weak adhesives. Optionally, the holding structure may have one or more textured surfaces in order to increase friction between the holding structure and the packaged device.
In general, it is desirable that the packaged device be firmly retained by the holding structure to facilitate transfer of the packaged device from the package to another location without the risk of dropping the packaged device. Once the packaged device is at the desired location, however, it should be simple and easy to then detach the packaged device from the holding structure, preferably without the user making direct contact with the packaged device. Accordingly, any releasable attachment structure that fulfills these functional goals, can be used in the various embodiments of the container of the present invention.
In the embodiment shown in
Second container portion 12 may include a variety of different grips to facilitate gripping of second container portion 12 to transfer the packaged device from container 10 to another location. For example, the holding structure can be shaped to receive the packaged device and provide a grip on the surface of second container portion 12 opposite the holding structure. Alternatively, one or more depressions or recesses of any suitable shape for facilitating gripping of second container portion 12 by one or more fingers can replace recesses 41. In another embodiment, the grip may be in the form of one or more protrusions that can interact with one or more of the user's fingers or the user's hand for facilitating gripping of second container portion 12. In a still further embodiment, the grip may be a pair of flat surfaces that are aligned so that two fingers can be used to pinch against the flat surfaces and hold second container portion 12. Also, combinations of two or more different types of grips can be employed.
Second container portion 12 may also include an orienting mechanism for facilitating placement of the packaged device in second container portion 12 with the device oriented in a particular orientation. In the embodiment shown in
A variety of different structures can serve as viable orienting mechanisms within the scope of the present invention. For example, the holding structure can be shaped to receive the packaged device only if it is inserted in the proper orientation. Alternatively, rectangular depression 39 can be replaced by a suitable depression of any shape that complements the shape of a structure on the packaged device that can be used to orient the device in the package. In another embodiment, the orienting mechanism may be a protrusion that fits into a corresponding recess in the packaged device. In a still further embodiment, the orienting mechanism may be a line or other mark which is to be aligned with a corresponding mark or structure on the packaged device to thereby ensure the proper orientation of the packaged device. Also, combinations of two or more orienting mechanisms can be employed.
In alternative embodiments, peripheral flange 34 may include releasable attachment members, not shown, to releasably secure second container portion 12 to first container portion 11. The releasable attachment members may be in the form of physical components that interlock, such as a slot and peg mechanism, or peripheral flange 32 of second container portion 12 may engage slits formed in, for example, raised portion 2 of peripheral flange 4 of first container portion 11. Also, snap-fit, friction-fit, releasable adhesive and/or hook and loop attachments, as well as other suitable, conventional releasable attachments, can be employed.
Other types of devices can be packaged in container 10. For example, brachytherapy devices, probes, knives, scissors, cutters, applicators, catheters, and other devices used in sterile environments may also be packaged in various embodiments of container 10 of the present invention. Also, hazardous devices may be packaged in container 10. A skilled person would be able to adapt container 10 to a particular device, using the present disclosure, by providing a suitable holding structure in second container portion 12. Container 10 could also be used for holding hazardous objects where directly grasping with the hands would be undesirable, such as, for example, devices that may include corrosive, irritant, poisonous or radioactive material, or other similarly hazardous materials. In this case, the barrier of second container portion 12 could act as a physical barrier to prevent contact with corrosive, irritant, or poisonous material, or as a radiation barrier to prevent transmission of radiation from the packaged device to the user.
Referring to
Distal portion 240 also includes a flexible, sterile sheath 246 extending from the distal end of distal portion 240, as shown. Flexible, sterile sheath 246 can be tucked under distal portion 240 for packaging in order to reduce the size of the container 10 required to house distal portion 240. For this purpose, container 10 may be designed to suspend second container portion 12 and the body of distal portion 240 above the bottom 8 of first container portion 11 when first and second container portions 11, 12 are associated with one another to allow some space for sterile sheath 246 to be tucked under distal portion 240 when located in container 10.
In a second aspect, the present invention provides a method for shipping devices that minimizes contamination of the devices during shipping and transfer of such devices out of the shipping container for use. In the method, a container is provided having first and second container portions. The second container portion is provided with a grip that is graspable by a user's hand and a holder for holding the device using that portion of the container. In the method, the device is first placed into the container. Then, upon opening the container, the user grasps the grip that forms part of the second container portion and removes the device from the container using the second container portion to manipulate the device. For example, the device can be attached to an articulating arm while held by the second container portion. In the final step of the method, the device is detached from the second container portion.
The method of the present invention may further include the step of orienting the device relative to the second container portion when placing the device in the second container portion. Holding the device in a particular orientation with the second container portion may facilitate manipulation of the device when it is transferred from the container to its point of use.
It is to be understood that even though numerous characteristics and advantages of the present invention have been set forth in the foregoing description, together with details of the structure and function of the invention, the disclosure is illustrative only, and changes may be made in detail, especially in matters of shape, size and arrangement of parts within the principles of the invention to the full extent indicated by the broad general meaning of the terms in which the appended claims are expressed.
