Chemistry: analytical and immunological testing – Composition for standardization – calibration – simulation,... – Preparation composition
Reexamination Certificate
1997-08-14
2001-05-01
Wallenhorst, Maureen M. (Department: 1743)
Chemistry: analytical and immunological testing
Composition for standardization, calibration, simulation,...
Preparation composition
C436S008000, C436S018000, C436S069000, C252S408100, C422S091000, C422S105000, C424S044000, C424S466000
Reexamination Certificate
active
06225123
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention is an additive preparation for use in collection devices wherein the additive preparation effervesces when in contact with a body fluid. The additive preparation desirably comprises a formulation comprising an additive such as a clot activator, anticoagulant or urine preservation material, an organic acid and a metal carbonate compound. The effervescence effect of the formulation aids in dispersal and delivery of the additive in a body fluid sample. The formulation is desirably tableted to provide an effective, easily stored and handled preparation. In particular, the formulation of the present invention preferably comprises a clot activator or anticoagulant, an organic acid and a metal carbonate compound wherein the formulation enhances clot activation or the anticoagulant effect in a blood specimen.
2. Description of Related Art
Blood collected in evacuated tubes often must be clotted prior to clinical examination because it is desirable to form a dense clot as rapidly and completely as possible to facilitate clean separation of the clot from the serum layer by centrifugation. To achieve this end, both plastic and glass blood collection tubes frequently employ a clot activator. Typical clot activators are diatomaceous earth and particles of inorganic silicates, or biochemicals such as ellagic acid, thrombin, trypsin and thromboplastin.
Typical clot activators used commercially are silica coated on fabric, silica particles in small plastic cups or silicate particles applied to the tube wall with a polyvinylpyrrolidone (PVP) carrier. However, in these type of arrangements, it is necessary for the user to initiate mixing of the sample so that the activator is bioavailabile to the specimen thus providing the desired effect of the additive in the sample. Therefore, the mixing requirement is critical to obtaining the desired effect of the additives.
Maximum effectiveness is achieved by thorough dispersion of the clot activator throughout the blood sample. Since clot activator materials are generally in powder form or as a wall coating, mixing of the clot activator with the blood sample to achieve dispersion may be a physically awkward operation. Also complete dispersion of the clot activator material in the blood sample tends to be frustrated by the tendency of the clot activator material to agglomerate upon moistening.
In addition, agglomerated clot activator particles tend to settle relatively rapidly, according to Stokes Law, which provides that the settling rate of a particle in a dispensing fluid will be governed by its relative diameter and density as well as the fluid's viscosity and density.
Therefore, there is a need for providing a means for deploying an additive in a body fluid with minimal requirements of the user to initiate mixing of the additive and the body fluid and whereby the additive is able to provide rapid and reliable performance under variable handling conditions.
More particularly, there is a need for a blood collection tube with means for promoting clot-acceleration of a blood sample which provides an enhanced rate of blood coagulation (shortened time for blood coagulation) without leaving any substantial amount of soluble or particulate material in the serum layer on centrifugation, thus avoiding potential interference with clinical tests, particularly in blood banking procedures. Whereas there are numerous commercial products available that employ clot activators, these products are unable to satisfactorily provide a shortened time for blood coagulation or provide a sample with minimal soluble or particulate material in the serum layer.
SUMMARY OF THE INVENTION
The present invention is an additive formulation for use in collection devices wherein the additive preparation effervesces when in contact with a body fluid. The additive preparation desirably comprises a formulation comprising an additive, an organic acid and a metal carbonate compound.
Desirably, the additive is a clot activator, anticoagulant, urine preservation material or any other body fluid preservative.
In addition, the additive formulation may further comprise a stabilizer and/or a flow improver or a binder.
Desirably, the additive formulation comprises:
(a) from about 40 weight percent to about 90 weight percent of an additive;
(b) from about 5 weight percent to about 30 weight percent of an organic acid or mixtures thereof; and
(c) from about 5 weight percent to about 30 weight percent of a metal carbonate compound.
The present invention is most preferably an additive formulation for enhancing clot activation of a blood sample. The additive formulation desirably comprises a clot activator, an organic acid and a metal carbonate compound.
Preferably, the clot activator additive formulation comprises:
(a) from about 40 weight percent to about 70 weight percent of a clot activator;
(b) from about 10 weight percent to about 25 weight percent of an organic acid or mixtures thereof; and
(c) from about 10 weight percent to about 25 weight percent of a metal carbonate.
The additive formulation may further comprise a binding agent from about 5 weight percent to about 30 weight percent of a binder.
The clot activator may be diatomaceous earth, particles of inorganic silicates or biochemicals such as ellagic acid, thrombin, trypsin and thromboplastin or combinations thereof.
A significant attribute of the additive formulation of the present invention is its use in collection devices wherein the additive preparation effervesces when in contact with a body fluid sample. The effect of the additive preparation therefore aids in the dispersal and delivery of the additive to a body fluid sample.
A significant attribute of the clot activator additive formulation of the present invention is its use in blood collection devices as an effective and efficient means for promoting blood coagulation. Most importantly is that the additive formulation and the blood sample does not have to be mixed by the user.
An important advantage of the clot activator additive formulation of the present invention is its ease of use not requiring lengthy time to promote blood coagulation as compared to conventional techniques.
Notably, the formulations of the present invention rapidly disintegrate and disperse in a body fluid sample, thereby minimizing the requirement that the user assist in mixing the formulation and the body fluid sample.
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Cohen Richmond R.
Dastane Ajit N.
Becton Dickinson and Company
Thomas, Esq. Nanette S.
Wallenhorst Maureen M.
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