The present invention relates to blood plasma storage containers and, more particularly, to such containers having locking caps.
Blood plasma is a straw-colored liquid component of whole blood, in which blood cells, such as red blood cells and white blood cells, and other components of the whole blood are normally suspended. Whole blood is made up of about 55%, by volume, plasma. Plasma plays important roles in a body's circulatory system, including transporting blood cells, conducting heat and carrying waste products. Pure plasma contains clotting factors, which increase the rate at which blood clots, making it useful in surgery and in the treatment of hemophilia. Banked whole blood is sometimes used to replace blood lost by patients during surgery or as a result of traumatic injuries. However, if banked whole blood of a type compatible with a patient is not available, plasma may sometimes be used to replace some of the lost blood. Furthermore, plasma may be frozen and stored for relatively long periods of time until it is needed.
Plasma is collected from donors. Sometimes, whole blood is collected from a donor, and plasma is separated from the other components of the donated whole blood later, such as in a laboratory. However, in other cases, the plasma is separated from the other components of the whole blood at the donation site, and the other components are returned to the circulation system of the donor. Apheresis is a medical technology in which the blood of a donor or patient is passed through an apparatus, such as a centrifuge, that separates out one particular constituent and returns the remainder to the donor or patient. Plasmapheresis is a medical therapy that involves separating blood plasma from whole blood.
Donated whole blood is typically stored in plastic bags. However, collected donated plasma is typically stored in plastic bottles. A typical plasma bottle includes a closed neck with at least one nipple for connecting plastic tubing. Often, two nipples are provided, one for introducing plasma into the bottle, and the other for venting air out of the bottle. After plasma has been collected in the bottle, the tubing is cut off using heat-sealing tongs, leaving short (typically about 1½ inch long) sealed tubing stubs attached to the nipples.
These stubs typically project from the bottle neck and may pose problems during transport and storage. For example, when the plasma is frozen, the plastic of the stubs becomes brittle and may break, thereby violating the requirement to keep the plasma in an aseptic container. Prior art plasma bottles have been designed to attempt to overcome problems associated with the stubs.
For example, German Utility Model DE 200 10 825 U 1, the entire contents of which are hereby incorporated by reference, discloses a plasma bottle with a rotatable protective cap with at least one slot. Two sealed tube stubs project through respective slots, until the cap is rotated. Rotating the cap draws the stubs inside the cap, where they are physically protected from impact. The cap includes a resilient rib and tabs on the inside cylindrical surface of the cap. The rib and tabs project radially inward. The bottle neck includes fins that project radially outward. The fins and the rib and tabs cooperate to create a stop to inhibit rotation of the cap from one of two positions. However, this design does not fully solve the problems associated with plasma collection bottles. For example, the stop is easily overcome. Furthermore, the cap may be relatively easily dislodged from the bottle, such as when several bottles are packaged together in a container for shipment or storage.
An embodiment of the present invention provides a container for collecting and storing blood plasma. The container includes a bottle and a cap. The bottle includes a neck, which includes a disc-shaped neck track. The track including a first key. For example, the key may be a rectangular member (as viewed in the plane of the neck track) that extends radially outward from the edge of the track. The container includes means for permitting fluid communication into and out of an interior of the bottle. A flexible tube may be attached at one end to the means for permitting fluid communication, and the flexible tube may be sealed at its other end. In some embodiments, the container includes two or more ports, each of which is in fluid communication with an interior of the bottle. Each port may include a nipple, to which a flexible tube may be connected. The other end of the tube may be sealed.
The cap is attachable to the neck of the bottle. (A cap that is already attached to the bottle is, nonetheless, referred to herein as being “attachable” to the bottle.) The cap has an internal cap track sized and positioned to cooperate with the neck track. The cap is configured to permit the cap to rotate about the neck track. The cap defines a slot. The slot is sized and positioned to interlock with the first key at a first (open) rotational position of the cap. When the cap is in this open position, the means for permitting fluid communication or the ports are accessible from outside the cap. For example, the tubes may extend through the slot.
The cap may also define a second key sized and positioned to interlock with the first key at a second (closed) rotational position of the cap. For example, the cap may define a pocket shaped to accept the key extending radially outward from the neck track. When the cap is rotated to the closed position, the means for permitting fluid communication or the ports are inaccessible, via the slot, from outside the cap.
To facilitate wrapping the tubes longitudinally around the container, the bottle has a bottom and a major longitudinal axis and defines a recess across a diameter of the bottom of the bottle. The cap may include two spaced-apart vanes extending in directions substantially parallel to the major longitudinal axis of the bottle. At the first rotational position of the cap, the vanes are substantially parallel to the recess in the bottom of the bottle.
At the first (open) rotational position of the cap, the means for permitting fluid communication or the ports are accessible from outside the cap via the slot. At the second (closed) rotational position of the cap, the means for permitting fluid communication or the ports are inaccessible from outside the cap via the slot.
A flexible tube may be attached at one end to the means for permitting fluid communication or to one of the ports, and the tube may be sealed at the other end. Similarly, a second flexible tube may be attached to the other port. The interior of the bottle may be sterile.
The key on the neck track may be radially proud of the neck track. As noted, the key on the neck track may be rectangular and extend radially away from the neck track. Thus, three edges of the key may be distinct from the circular shape of the neck track. These three edges may lie in a plane of the neck track. The second edge may be parallel to a line tangent to the neck track.
The cap may define the second key as a recess shaped to accept the first key.
The cap may include one or more radially inwardly projecting tabs on an inside wall of the cap. Each tab may define at least part of the internal cap track. Each tab may be located proximate a circumferential edge of the cap. In addition, the cap may include at least one radially inwardly projecting track element on an inside wall of the cap. Each track element may be spaced from the circumferential edge of the cap a distance selected to accommodate the disc-shaped neck track between the tab(s) and the track element(s). Each tab may be sized and configured to at least partially prevent a top of another cap from nesting within the cap. The cap shape may be configured to at least partially prevent nesting of the cap within another cap.
The invention will be more fully understood by referring to the following Detailed Description of Specific Embodiments in conjunction with the Drawings, of which:
Embodiments of the present invention include containers having locking caps for storing blood plasma and protecting tube stubs during storage and transportation. One such container includes a bottle having a neck and a cap rotatably attached to the neck. The bottle and the cap may define structures that facilitate storing and protecting tubing wrapped longitudinally around the container, until the container is used to collect and store plasma. The cap and the neck are configured to lock the cap in at least one, and preferably two, rotational positions. In one position, the tubes connected to the container are accessible. After the plasma has been collected and the tubes have been cut off and sealed, in the other position, the tube stubs are protected by the cap.
During manufacture, the tubes 110 may be connected to the container 100. To facilitate storage and transportation of the container 100 before it is used, the tubes 110 may be wrapped longitudinally around the container 100, as shown in
Returning to
Thus, collectively, the vanes 116 and the recess 113 provide guides, within which the tubes 110 may be wrapped. Wrapping the tubes 110 around the container 100 and within the vanes 116 and the recess 113 prevents the tubes 110 from kinking or becoming entangled with tubes connected to other containers during shipment and storage. In addition, the vanes 116 and the recess 113 protect the tubes 110 from damage during shipment and storage, when similar containers may be stacked on top of one another. In this regard, the vanes 116 may be configured to be tall enough, and the recess 113 may be configured to be deep enough, to protect the tubes 110 from being contacted or crushed by other containers.
As shown in
One end of each of the tubes 110 (
After plasma has been collected and stored in the container 100, the tubes 110 may be cut off and heat sealed, as is well known in the art. The neck portion of the container 100, after the tubes 110 have been cut off and sealed, is shown in
In preparation for closing the cap 106, the stubs 700 should be folded inward toward each other, and the ends of the stubs 700 should be tucked in to the space between the nipples 410, as shown in
In either case, once the stubs 700 are tucked in, the cap 106 may be rotated approximately 180 degrees in either direction, as indicated by the arrow 108. As shown in
As noted, the cap 106 locks in one, or preferably two, rotational positions. In a first position (shown in
The annular track 1133 is sized and configured to accommodate and capture the disc-shaped platform 403 within the track 1133. In other words, the distance 1136 between the opposite-facing surfaces 1123 and 1126 is approximately equal to the thickness 420 (
As noted, the disc-shaped platform 403 is captured within the track 1133. “Captured” here means the cap 106 may be rotated about the disc-shaped platform 403; however, more force than would normally be applied during use of the container 100 is required to remove the cap 106 from the platform 403, and continued rotation of the cap 106 does not unscrew the cap 106 from the bottle 103. Thus, the cap 106 remains attached to the bottle 103 more robustly than in the prior art. As noted, the cap 106 is attached to the bottle 103, meaning the cap 106 is captured.
A shoulder portion 1000 (
To facilitate locking the cap 106 in one of the two rotational positions, the platform 403 includes a radially outwardly projecting key 423 (best seen in
To facilitate locking the cap 106 in the other of the two rotational positions, the cap defines a pocket 1153 (best seen in
In addition to providing fluid communication between the nipples 410 and the interior of the bottle 103, the raised curved structure 406 (
As noted with respect to
By applying sufficient rotational force, the cap 106 can be rotated away from the closed position. However, the force necessary of overcome the resistance of the key 423 being captured by the pocket 1153 is greater than the force necessary to overcome the resistance of the key 423 being captured by the slot 800, because the pocket 1153 is defined by solid material, whereas the slot 800 is open.
As noted with respect to
Although an embodiment with a key 423 (
While the invention is described through the above-described exemplary embodiments, it will be understood by those of ordinary skill in the art that modifications to, and variations of, the illustrated embodiments may be made without departing from the inventive concepts disclosed herein. Furthermore, disclosed aspects, or portions of these aspects, may be combined in ways not listed above. Accordingly, the invention should not be viewed as being limited to the disclosed embodiment(s).
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US10/34569 | 5/12/2010 | WO | 00 | 1/23/2013 |