Blood collection device containing lysophospholipase inhibitor

Patent metadata

Field	Value
Publication number	US-9459187-B2
Application number	US-201214003033-A
Country	US
Kind code	B2
Filing date	Mar 2, 2012
Priority date	Mar 4, 2011
Publication date	Oct 4, 2016
Grant date	Oct 4, 2016

Abstract

Disclosed are collection devices for collecting and stabilizing whole blood or a component thereof, which include a first end and a second end and at least one interior wall defining a reservoir, wherein the reservoir contains a stabilization agent that includes a lysophospholipase (LysoPLA) inhibitor. Also disclosed are methods for making and using the devices.

First claim

The invention claimed is:

1. A collection device for collecting whole blood or a fluid component thereof, comprising a first end and a second end and at least one interior wall defining a reservoir, wherein the reservoir comprises a stabilization agent comprising a lysophospholipase (LysoPLA) inhibitor which stabilizes acylated proteins and acylated peptides that may be present in the collected whole blood or fluid component thereof, wherein the device further comprises an anti-coagulant, and wherein the device is a tube that is at least partially evacuated and which further comprises a closure pierceable by a needle for supplying blood to the reservoir.

2. The device of claim 1 , wherein the tube is sterile.

3. The device of claim 1 , wherein the interior wall comprises plastic or glass.

4. The device of claim 1 , wherein the reservoir comprises a separating element.

5. The device of claim 1 , wherein the LysoPLA inhibitor is methyl arachidonyl fluorophosphonate (MAFP).

6. The device of claim 1 , wherein the LysoPLA inhibitor is selected from the group consisting of bromoenol lactone, ethyl octylphosphonofluoridate, isopropyl dodecylphosphonofluoridate, n-dodecyl-benzodioxaphosphorine 2-oxide, bromoenol lactone, palmityl trifluoromethyl ketone and palmitoyl carnitine.

7. The device of claim 1 , wherein the stabilization agent further comprises a butylcholinesterase (BChE) inhibitor, an acetylcholinesterase (AChE) inhibitor, or a combination thereof.

8. The device of claim 7 , wherein the BChE inhibitor is tacrine, or a derivative thereof.

9. The device of claim 1 , wherein the stabilization agent further comprises a protease inhibitor.

10. The device of claim 9 , wherein the protease inhibitor is an inhibitor of a serine protease, an inhibitor of an endoprotease, an inhibitor of an exopeptidase, an inhibitor of a dipeptidyl peptidase, or a combination of two or more thereof.

11. The device of claim 1 , wherein the stabilization agent is Lyophilized.

12. The device of claim 1 , wherein the anti-coagulant is EDTA or a salt thereof, or heparin.

13. The device of claim 12 , wherein the anti-coagulant is coated or spray-dried onto at least a portion of the interior wall.

14. The device of claim 1 , wherein the stabilization agent excludes an esterase inhibitor.

15. A method for collecting whole blood or a fluid component thereof, comprising collecting whole blood or the fluid component thereof from a patient into the device of claim 1 .

16. The method of claim 15 , wherein the whole blood or fluid component thereof is obtained from a diabetes patient.

17. The method of claim 15 , wherein the fluid component is plasma.

18. A method for diagnosing a metabolic disease or monitoring treatment of a patient with a metabolic disease, comprising measuring at at least one predetermined time the presence or amount of ghrelin in a sample of whole blood or fluid component thereof, wherein the blood was collected from the patient into a collection device for collecting whole blood or a fluid component thereof, comprising a first end and a second end and at least one interior wall defining a reservoir, wherein the reservoir comprises a stabilization agent comprising a lysophospholipase (LysoPLA) inhibitor which stabilizes acylated proteins and acylated peptides that may be present in the collected whole blood or fluid component thereof, wherein a measured amount higher than a control is indicative of the presence of a metabolic disease, or efficacy of therapy.

19. A method for detecting the presence or amount of a prodrug and/or an active metabolite thereof in whole blood or a fluid component thereof, comprising detecting the presence or measuring the amount of a prodrug that bears an aliphatic ester group in a sample of blood or fluid component thereof, from a patient who has been administered the prodrug, wherein the blood or fluid component thereof was collected into a collection device of for collecting whole blood or fluid component thereof, comprising a first end and a second end and at least one interior wall defining a reservoir, wherein the reservoir comprises a stabilization agent comprising a lysophospholipase (LysoPLA) inhibitor which stabilizes acylated proteins and acylated peptides that may be present in the collected whole blood or fluid component thereof, and comparing the detected presence or measured amount to a control.

20. A collection device for collecting whole blood or a fluid component thereof, comprising a first end and a second end and at least one interior wall defining a reservoir, wherein the reservoir comprises a stabilization agent comprising a lysophospholipase (LysoPLA) inhibitor which stabilizes acylated proteins and acylated peptides that may be present in the collected whole blood or fluid component thereof, and a protease inhibitor, and wherein the device further comprises two or more protease inhibitors.

21. A collection device for collecting whole blood, or a fluid component thereof, comprising a first end and a second end and at least one interior wall defining a reservoir, wherein the reservoir comprises a stabilization agent comprising a lysophospholipase (LysoPLA) inhibitor which stabilizes acylated proteins and acylated peptides that may be present in the collected whole blood or a fluid component thereof, and a butylcholinesterase (BChE) inhibitor, an acetylcholinesterase (AChE) inhibitor, or a combination thereof.

22. A method for collecting whole blood , comprising collecting whole blood or a fluid component thereof from a diabetes patient into a device for collecting whole blood, comprising a first end and a second end and at least one interior wall defining a reservoir, wherein the reservoir comprises a stabilization agent comprising a lysophospholipase (LysoPLA) which stabilizes acylated proteins and acylated peptides that may be present in the collected whole blood or fluid component thereof.

23. A method for collecting whole blood or plasma, comprising collecting blood or plasma from a patient into a device for collecting whole blood or plasma, comprising a first end and a second end and at least one interior wall defining a reservoir, wherein the reservoir comprises a stabilization agent comprising a lysophospholipase (LysoPLA) which stabilizes acylated proteins and acylated peptides that may be present in the collected whole blood or plasma.

24. The device of claim 20 , which is a tube that is at least partially evacuated and which further comprises a closure pierceable by a needle for supplying blood to the reservoir.

25. The device of claim 21 , which is a tube that is at least partially evacuated and which further comprises a closure pierceable by a needle for supplying blood to the reservoir.

26. The device of claim 20 , further comprising an anticoagulant.

27. The device of claim 21 , further comprising an anticoagulant.

28. A method for collecting whole blood or a fluid component thereof, comprising collecting whole blood or fluid component thereof from a patient into the device of claim 9 .

29. The method of claim 28 , wherein the patient is a diabetic and the acylated proteins and acylated peptides that may be present in the collected whole blood or fluid component thereof comprise glucagon, GIP( 1-42) , GLP-1-(7-36)NH 2 , GLP-1-(7-37), or a combination of two or more thereof.

30. The method of clai

Assignees

• Craft David
• Apte Priyanka
• Becton Dickinson Co

Inventors

• Craft David
• Apte Priyanka

Classifications

• 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

• A61B5/154

  {Devices} using pre-evacuated means · CPC title

• G01N1/28 Primary

  Preparing specimens for investigation {including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q}(mounting specimens on microscopic slides G02B21/34; means for supporting the objects or the materials to be analysed in electron microscopes H01J37/20 {; laboratory gas handling apparatus B01L5/00}) · CPC title

• A61B5/150755

  Blood sample preparation for further analysis, e.g. by separating blood components or by mixing · CPC title

• A61B5/150099

  by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes · CPC title