Blood collection devices containing blood stabilization agent including variegin or analog thereof and/or a polysulfated disaccharide

Patent metadata

Field	Value
Publication number	US-10299714-B2
Application number	US-201113310084-A
Country	US
Kind code	B2
Filing date	Dec 2, 2011
Priority date	Dec 2, 2010
Publication date	May 28, 2019
Grant date	May 28, 2019

Abstract

Disclosed are devices for collecting and stabilizing blood that contain a blood stabilization agent which includes variegin or an analog thereof, a polysulfated disaccharide, or a combination thereof, each in an amount effective to stabilize blood. Methods of making and using the devices, and kits containing the devices, are also provided.

First claim

The invention claimed is:

1. A device for collecting and stabilizing platelet function in a collected blood sample, wherein the device has a first end and a second end and at least one interior wall defining a reservoir portion for receiving the blood sample, wherein the reservoir comprises an anti-coagulant and a platelet stabilization agent comprising variegin having an amino acid sequence designated as SEQ ID NO: 1, or a fragment thereof, wherein the fragment is selected from the group consisting of SEQ ID NOS: 2-5 and analogs of such fragments, the analog fragments selected from the group consisting of SEQ ID NOS: 6-16, either alone or in combination with a polysulfated disaccharide each in an amount effective to stabilize platelets in the blood collected by the device for at least about twenty-four hours, wherein the device is sterile, at least partially evacuated and which further comprises a closure pierceable by a needle.

2. The device of claim 1 , which is evacuated.

3. The device of claim 1 , which is a tube.

4. The device of claim 3 , which further comprises a separator.

5. The device of claim 1 , wherein the variegin is present in the device in a concentration of about 1 μm to about 1 mM.

6. The device of claim 1 , wherein the polysulfated disaccharide is sucrose octasulfate.

7. The device of claim 1 , wherein the platelet stabilization agent comprises the polysulfated disaccharide and which is present in the device in a concentration of about 50 μm to about 50 mM.

8. The device of claim 1 further comprises a direct thrombin inhibitor.

9. The device of claim 8 , wherein the direct thrombin inhibitor is selected from the group consisting of argatroban, rOicPaF(p-Me)—NH 2 , hirudin, bivalirudin, aprotinin, and D-phenylalanyl-L-prolyl-L-arginine (PPACK), and combinations of two or more thereof.

10. The device of claim 1 further comprises an indirect thrombin inhibitor.

11. The device of claim 10 , wherein the indirect thrombin inhibitor is selected from the group consisting of heparin and low molecular-weight heparins.

12. The device of claim 1 , wherein the platelet stabilization agent is in dried form.

13. The device of claim 1 , wherein the anti-coagulant is selected from the group consisting of antistasin, argatroban, E-76, antithrombin III, Factor Xa inhibitors, Factor VII inhibitors, Factor IX inhibitors, Fractor XII inhibitors and Factor II inhibitors, and combinations of two or more thereof.

14. The device of claim 13 , wherein the Factor Xa inhibitors are selected from the group consisting of 6-(4-{1-[(dimethylamino)methyl]cyclopropyl}phenyl)-1-(4-methoxyphenyl)-3-(trifluoromethyl)-1,4,5,6-tetrahydro-7H-pyrazolo[3,4-c]pyridin-7-one; and 1-(4-methoxyphenyl)-6-[4-[1-(pyrrolidin-1-ylmethyl)cyclopropyl]phenyl]-3-(trifluoromethyl)-4,5-dihydropyrazolo[3,4-c]pyridin-7-one, and combinations thereof.

15. The device of claim 1 , wherein the reservoir further comprises a platelet antagonist.

16. The device of claim 15 , where the platelet antagonist is selected from the group consisting of cyclooxygenase inhibitors, P2Y12 inhibitors, and anti-platelet antibodies, and combinations of two or more thereof.

Assignees

• Gelfand Craig A
• Marchiarullo Daniel
• Moskowitz Keith
• Becton Dickinson Co

Inventors

• Gelfand Craig A
• Marchiarullo Daniel
• Moskowitz Keith

Classifications

• A61B5/154 Primary

  {Devices} using pre-evacuated means · CPC title

• A61B5/150351

  Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel · CPC title

• A61B5/150305

  Packages specially adapted for piercing devices or blood sampling devices · CPC title

• A61B5/150251

  Collection chamber divided into at least two compartments, e.g. for division of samples (injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755) · CPC title

• B01L3/5082

  Test tubes per se · CPC title