Surgery – Container for blood or body treating material – or means used...
Reexamination Certificate
2000-08-02
2003-06-03
Sykes, Angela D. (Department: 3762)
Surgery
Container for blood or body treating material, or means used...
C604S403000
Reexamination Certificate
active
06572603
ABSTRACT:
TECHNICAL FIELD
The present invention relates to a polyolefin-made holder for a vitamin D solution, which minimizes reduction in vitamin D content, and to a transfusion fluid container that accommodates the holder.
BACKGROUND ART
In many cases, patients who have undergone surgery on the digestive tract cannot ingest nutrition orally. Therefore, in order to provide nutrition to such patients, intravenous hyperalimentation (IVH) is generally carried out. IVH facilitates an improvement in the nutritional status of the aforementioned patients and maintenance of the improved nutritional status, and thus promotes recovery and healing in these patients. Therefore, IVH is considered to be very effective, and at present IVH is widely employed in the field of surgical treatment.
In IVH, carbohydrates and amino acids, serving as nutritional sources, and electrolytes are usually administered. Transfusion products containing all of these sources have been developed for IVH, and generally, commercially available products are of the type in which two containers, one containing glucose and the other containing amino acids (here the glucose and amino acids are known to induce the Maillard reaction).
When IVH is carried out for a relatively prolonged period of time, problems can arise. For example, lack of trace elements and vitamins which are not contained in the transfusion products may lead to malnutrition. Particularly, vitamin B
1
is consumed in glucose metabolism, and thus tends to be lacking, inducing grave acidosis. Therefore, when IVH is prolonged beyond a certain short period of time (e.g., approximately one week), vitamins must be co-administered. Due to the unstable nature of vitamins, vitamins are formulated singly and supplied in the form of a vitamin mixture or a multi-vitamin preparation, and such vitamins are mixed with an IVH product in a clinical setting, such as a hospital, at the time of use. However, carrying out such a mixing operation in a hospital is cumbersome. In addition, the IVH product may become contaminated with bacteria during the mixing process, and thus the operation requires efficiency and care. This imposes an excessive workload on the person who administers IVH.
In order to make the aforementioned mixing operation more convenient, attempts have been made to produce a two-container-type IVH product which incorporates the vitamins. For example, fat and sugar are contained in one of two containers, amino acids and electrolytes are contained in the other, and a variety of vitamins can then be incorporated into either of the two containers (Japanese Patent Application Laid-Open Nos. 6-209979 and 8-709).
Fat, which is an important component of nutrition, is also incorporated into IVH products. However, fat must not be administered to patients suffering hyperlipidemia, liver dysfunction, thrombosis, or diabetic ketosis. Suitable dosage of fat may vary among patients, and in some cases, it may be preferable to administer fat alone.
However, in the aforementioned IVH product, particular vitamins are stabilized by incorporation of fat, and thus, maintaining the stability of vitamins (e.g., vitamin B
2
) without fat is difficult.
In general, transfusion fluid containers which are produced from polyolefin, such as polyethylene or polypropylene, are widely employed, since such containers are easy to shape and are considered safe. However, when a solution containing vitamin D among other vitamins is stored in the aforementioned polyolefin-made container for a prolonged period of time, the vitamin D is adsorbed into the container and the vitamin content of the solution is lowered considerably. As a result, malabsorption of calcium, or bone embrittlement due to vitamin D deficiency may arise in patients who have undergone transfusion of fluids that have been stored in such containers.
Studies have been carried out on a variety of kit-type transfusion fluid containers in which holders containing substances such as vitamins are separately prepared and the holders are connected to the containers. For example, Japanese Patent Application Laid-Open (kokai) No. 6-54889 discloses a bag assembly in which syringes are connected. In such transfusion fluid containers, when holders for containing drugs are produced from a material which does not adsorb vitamin D, such as glass, the aforementioned problem can be avoided. However, the holders can be associated with higher production costs, and dismantling of the holders for separate disposal after use can be laborious.
In view of the foregoing, an object of the present invention is to provide a polyolefin-made holder for a vitamin D solution, which minimizes any reduction in vitamin D content, and a transfusion fluid container incorporating the holder.
DISCLOSURE OF THE INVENTION
In order to solve the aforementioned problems, the present inventors have performed extensive studies and have found that even when polyolefin, which adsorbs vitamin D, is employed in a holder, reduction in vitamin D content can be limited to an acceptable range when the volume of polyeolefin constituting a solution-holding portion of the holder is a predetermined amount or less. The present invention has been accomplished on the basis of this finding.
Accordingly, the present invention provides a polyolefin-made holder for a vitamin D solution containing vitamin D or a derivative thereof, wherein the volume of polyolefin constituting the solution-holding portion of the holder is 30 cm
3
or less per &mgr;mol of the vitamin D or derivatives thereof.
The present invention also provides a transfusion fluid container, which is flexible and accommodates the holder for the vitamin D solution.
REFERENCES:
patent: 4997083 (1991-03-01), Loretti et al.
patent: 5385737 (1995-01-01), Shigeno et al.
patent: 5423421 (1995-06-01), Inoue et al.
patent: 5425447 (1995-06-01), Farina
patent: 5738871 (1998-04-01), Story
patent: 5925381 (1999-07-01), Boyle et al.
patent: 8-191873 (1996-07-01), None
Patent abstract of Japan, 08191873. 07/30/96.
Intermational Search Report.
Kaga Junji
Kobatake Hideki
Sekimoto Shigehito
Tani Seiji
Deak Leslie
Otsuka Pharmaceutical Factory Inc.
Sykes Angela D.
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