Apparatus for inhibiting glycolysis in blood samples

• US 5,955,371 A
• Filed: 11/13/1997
• Issued: 09/21/1999
• Est. Priority Date: 08/09/1994
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Ikeda, Tatsuhiko, Dastane, Ajit N., Losada, Robert
• Primary Examiner(s): SAUNDERS, DAVID A
• Application Number:
  US08/969,628
• Time in Patent Office: 677 Days
• Field of Search: 422/61, 422/41, 422/102, 436/8, 436/17, 436/18, 436/176, 436/810, 436/826, 436/67, 436/87, 435/2, 435/296, 435/299, 435/232, 435/288.1, 435/307.1, 252/380, 252/182.29, 604/403, 604/416
• US Class Current: 436/18
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150351 Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel caps for bottles or containers in general B65D41/00
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/154 Devices using pre-evacuated means
• CPC Class Codes: B01L 3/5082 Test tubes per se
• CPC Class Codes: C12Q 1/56 involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
• CPC Class Codes: G01N 2400/40 Glycosaminoglycans, i.e. GAG or mucopolysaccharides, e.g. chondroitin sulfate, dermatan sulfate, hyaluronic acid, heparin, heparan sulfate, and related sulfated polysaccharides
• CPC Class Codes: Y10T 436/108331 Preservative, buffer, anticoagulant or diluent
• CPC Class Codes: Y10T 436/2525 Stabilizing or preserving

Abstract

A blood collection device comprising formed additive particles. The additive particles are an improvement over available additive formulations that are powder blended in that the components of the additive particles of the present invention are in each formed particle. The formed additive particles comprise a fluoride salt and an ethylenediaminetetraacetate salt or a heparin salt to consistently minimize glycolysis and coagulation of a blood specimen with low hemolysis.

Claims

1. An article of manufacturing comprising, a blood collection tube containing granulated additive particles wherein each particle comprises a fluoride salt component and an anticoagulant component wherein said particles have a mesh size from 130 to 350.

2. The article of claim 1 wherein the mesh size of said particles are from 130 to 180.

3. The article of claim 1 wherein said fluoride salt is selected from the group consisting of sodium fluoride, lithium fluoride, potassium fluoride and ammonium fluoride.

4. The article of claim 3 wherein said fluoride salt is sodium fluoride.

5. The article of claim 1, wherein said blood collection device is plastic.

6. The article of claim 1 wherein said anticoagulant is selected from the group consisting of an ethylenediaminetetraacetate salt and a heparin salt.

7. The article of claim 6 wherein said ethylenediaminetetraacetate salt is selected from the group consisting of ethylenediaminetetraacetate disodium and ethylenediaminetetraacetate dipotassium.

8. The article of claim 6 wherein said heparin salt is selected from the group consisting of sodium heparin, lithium heparin and ammonium heparin.

9. The article of claim 6, wherein said additive particle, per 1 ml of blood, comprises:

(a) about 1.0 mgs to about 10.0 mgs of a fluoride salt; and

(b) about 1.0 mgs to about 10.0 mgs of an ethylenediaminetetraacetate salt or about 1.0 USP to about 20.0 USP of a heparin salt.

10. The article of claim 6 wherein said additive particle, per 1 ml of blood, comprises about 1.5 mg of a fluoride salt component and about 3.0 mg of an ethylenediaminetetraacetate salt.

11. A granulated additive particle formulation for use in blood collection tubes to minimize glycolysis and blood coagulation with low hemolysis, comprising a fluoride salt component and an anticoagulant component, wherein each particle has a mesh size from 130 to 350.

12. The additive of claim 11 wherein the mesh size of said particle is from 130 to 180.

13. The additive of claim 11 wherein said fluoride salt is selected from the group consisting of sodium fluoride, lithium fluoride, potassium fluoride and ammonium fluoride.

14. The additive of claim 13 wherein said fluoride salt is sodium fluoride.

15. The additive of claim 13 wherein said anticoagulant is selected from the group consisting of an ethylenediaminetetraacetate salt and a heparin salt.

16. The additive of claim 15 wherein said ethylenediaminetetraacetate salt is selected from the group consisting of ethylenediaminetetraacetate disodium and ethylenediaminetetraacetate dipotassium.

17. The additive of claim 15 wherein said heparin salt is selected from the group consisting of sodium heparin, lithium heparin and ammonium heparin.

18. The additive of claim 15 per 1 ml of blood, comprising:

(a) 1.0 mg to 10.0 mg of a fluoride salt; and

(b) 1.0 mg to 10.0 mg of an ethylenediaminetetraacetate salt or 1.0 USP to 20.0 USP of a heparin salt.