CLOTTING CASCADE INITIATING APPARATUS AND METHODS OF USE AND METHODS OF CLOSING WOUNDS

• US 20110046574A1
• Filed: 10/29/2010
• Published: 02/24/2011
• Est. Priority Date: 06/01/1999
• Status: Active Grant

• Current Assignee: Daniel G. Ericson, Edward T. Joseph, James E. Olson, Karol L. Nowakowski
• Original Assignee: Daniel G. Ericson, Edward T. Joseph, James E. Olson, Karol L. Nowakowski
• Inventors: Ericson, Daniel G., Nowakowski, Karol L., Joseph, Edward T., Olson, James E.
• Granted Patent: US 8,343,084 B2
• Time in Patent Office: Days
• US Class Current: 604/257
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: Y10T 428/2996 Glass particles or spheres
• CPC Class Codes: Y10T 428/31928 Ester, halide or nitrile of addition polymer

Abstract

A wound closure apparatus is provided which utilizes blood fluid by activating the clotting cascade of blood fluid outside the body within a substantially enclosed sterile container then introducing the blood fluid to the wound site to complete clotting. An apparatus for providing ways of inhibiting anticoagulating agents and slowing fibrin clot degradation are also disclosed. Kits for practicing the invention singularly or in combination with and/or associated with preferred procedures are also disclosed. The invention provides a clotting cascade initiation apparatus including a substantially enclosed sterile containment chamber within which an aliquot of blood fluid, either autologous or from donor sources, can be received and retained. In preferred embodiments, the sterile containment chamber further includes a heparin binding agent which will bind heparin and remove it from the blood fluid. In further embodiments, the containment chamber will also include a procoagulating agent, wherein a clotting cascade can be initiated when the blood fluid is accepted into the sterile containment chamber.

Claims

1. A method for treating a wound in a patient comprising:

withdrawing unanticoagulated whole blood from the patient;

anticoagulating the unanticoagulated whole blood in a first container to generate anticoagulated blood;

reversing anticoagulation in at least a portion of the anticoagulated blood in a second container to generate reversed blood, wherein the reversed blood is capable of clot formation; and

treating the wound with at least a portion of the reversed blood, wherein the treating comprises transferring the portion of the reversed blood from the second container to the patient without passing through the first container.

2. The method of claim 1 wherein the transferring the portion of the reversed blood from the second container to the patient includes transferring through a fluid communication device selected from the group consisting of a venous in-dwelling patient line, an arterial in-dwelling patient line, a catheter, an introducer sheath, a needle, and an angiocath.

3. The method of claim 1 further comprising, between the anticoagulating and the reversing steps, transferring at least a portion of the anticoagulated blood from the first container to the second container.

4. The method of claim 1 further comprising transferring the whole blood from the patient to the first container, wherein the transferring the whole blood from the patient to the first container and the transferring the reversed blood from the second container to the patient is performed through a common fluid communication device.

5. The method of claim 1 wherein the withdrawing is performed with a blood collection apparatus that is separable from direct fluid communication with the body.

6. The method of claim 1 further comprising, between the withdrawing step and the treating step, containing the unanticoagulated whole blood, the anticoagulated blood, or the reversed blood within a container.

7. The method of claim 6 wherein the container is selected from the group consisting of a blood collection container, a syringe, a cartridge, a vial, a test tube, a jar, a bag, a balloon, a pouch, a tray, a dish, a bowl, a tube, a catheter, a cannulae, an introducer sheath, and an angiocath.

8. The method of claim 6 wherein the container comprises the first container.

9. The method of claim 1 wherein the anticoagulating step includes treating the unanticoagulating blood with a calcium chelator.

10. The method of claim 9 wherein the calcium chelator is selected from the group consisting of citrate, acid citrated dextrose, EDTA, and EGTA.

11. The method of claim 1 wherein the anticoagulating step includes treating the unanticoagulated blood with a negatively charged anticoagulating agent.

12. The method of claim 11 wherein the negatively charged anticoagulating agent is selected from the group consisting of heparin and hirudin.

13. The method of claim 1 wherein second container in the reversing step comprises a cartridge including an agent capable of reversing anticoagulation.

14. The method of claim 13 wherein the cartridge comprises a substrate selected from the group consisting of polystyrene, glass, polypropylene, polymethylmethracrylate, urethane, polyethylene, and woven fabric.

15. The method of claim 1 wherein the reversing includes exposing the portion of the anticoagulated blood to an agent that interacts with the portion of the anticoagulated blood in a manner selected from the group consisting of binding the anticoagulating agent so as to substantially remove the anticoagulating agent from the blood fluid, degrading the anticoagulating agent so as to make the anticoagulating agent ineffective as an anticoagulating agent, and binding to the negatively charged anticoagulating agent so as to make the negatively charged anticoagulating agent substantially ineffective as an anticoagulating agent which inhibits or impedes either the initiation or the continuance of a clotting cascade within the blood fluid.

16. The method of claim 1 wherein the reversing includes cationic exchange.

17. The method of claim 1 wherein the reversing includes exposing the portion of the anticoagulated blood to an immobilized, positively charged chemical species.

18. The method of claim 1 wherein the reversing includes exposing the portion of the anticoagulated blood to an agent selected from the group consisting of polyethyleneimine and derivatized polyethyleneimine.

19. The method of claim 1 wherein the reversing includes exposing the portion of the anticoagulated blood to an agent selected from the group consisting of DEAE, aminoacetylized functional groups, heparinase, protamine sulfate, platelet factor IV, and thrombin.

20. The method of claim 1 further including treating the anticoagulated blood or reversed blood with a procoagulant.

21. The method of claim 20 wherein the treating with the procoagulant initiates a clotting cascade during a first time period such that at least a portion of the reversed blood will form a clot during a second time period subsequent to the first time period.

22. The method of claim 20 wherein the procoagulant is a polymer.

23. The method of claim 20 wherein the procoagulant is selected from the group consisting of cotton, collagen, polyethylene, polycarbonate, polypropylene, ethylenevinyl alcohol, cellulose acetate, urethane, silicone, glass, metal, ceramic, thrombin, mechanical agitation, and mechanical shear.

24. The method of claim 20 wherein the procoagulant is not applied to the wound in the treating step.

25. The method of claim 1 wherein the treating step further comprises introducing the portion of the reversed blood to vicinity of the wound.

26. A system for closing a wound in a patient comprising:

a first container that accommodates a volume of whole blood from the patient;

an anticoagulating agent for treating the whole blood in the first container to generate anticoagulated blood;

a reversing agent in a second container which substantially reduces anticoagulating effect of the anticoagulating agent to generate reversed blood; and

an apparatus comprising the first and second containers for transferring the whole blood from the patient to the first container, for treating the whole blood with the anticoagulating agent, for treating at least a portion of the anticoagulated blood with the reversing agent, and for transferring the reversed blood to the patient.

27. The system of claim 26 wherein the apparatus includes a fluid communication device selected from the group consisting of a venous in-dwelling patient line, an arterial in-dwelling patient line, a catheter, an introducer sheath, a needle, and an angiocath for transferring the whole blood from the patient to the first container, transferring the reversed blood to the patient, or transferring the whole blood from the patient to the first container and transferring the reversed blood to the patient.

28. The system of claim 26 wherein the apparatus includes a common fluid communication device to transfer the whole blood from the patient to the first container and to transfer the reversed blood to the patient.

29. The system of claim 26 wherein the second container includes multiple chambers, at least one of which accommodates the anticoagulated blood and at least a second of which accommodates the reversing agent.

30. The system of claim 26 wherein the anticoagulating agent includes a calcium chelator.

31. The system of claim 30 wherein the calcium chelator is selected from the group consisting of citrate, acid citrated dextrose, EDTA, and EGTA.

32. The system of claim 26 wherein the anticoagulating agent includes a negatively charged anticoagulating agent.

33. The system of claim 32 wherein the negatively charged anticoagulating agent is selected from the group consisting of heparin and hirudin.

34. The system of claim 26 wherein the apparatus includes a cartridge comprising the reversing agent.

35. The system of claim 34 wherein the cartridge comprises a substrate selected from the group consisting of polystyrene, glass, polypropylene, polymethylmethracrylate, urethane, polyethylene, and woven fabric, wherein the reversing agent is immobilized on the substrate.

36. The system of claim 35 wherein the cartridge includes a configuration selected from the group consisting of a tubular flow path, beads, matted fiber, and hollow fiber.

37. The system of claim 26 wherein the reversing agent is structured to interact with the anticoagulating agent in a manner selected from the group consisting of binding the anticoagulating agent so as to substantially remove the anticoagulating agent from the blood fluid, degrading the anticoagulating agent so as to make the anticoagulating agent ineffective as an anticoagulating agent, and binding to the anticoagulating agent so as to make the anticoagulating agent substantially ineffective as an anticoagulating agent which inhibits or impedes either the initiation or the continuance of a clotting cascade within the blood fluid.

38. The system of claim 26 wherein the reversing agent is an immobilized, positively charged chemical species.

39. The system of claim 26 wherein the reversing agent is polyethyleneimine or derivatized polyethyleneimine.

40. The system of claim 26 wherein the reversing agent is selected from the group consisting of DEAE, aminoacetylized functional groups, heparinase, protamine sulfate, platelet factor IV, and thrombin.

41. The system of claim 26 further comprising a procoagulating agent to initiate the clotting cascade in the reversed blood.

42. The system of claim 41 wherein the procoagulant is a polymer.

43. The system of claim 41 wherein the procoagulant is selected from the group consisting of cotton, collagen, polyethylene, polycarbonate, polypropylene, ethylenevinyl alcohol, cellulose acetate, urethane, silicone, glass, metal, ceramic, thrombin, mechanical agitation, and mechanical shear.

44. The system of claim 41 wherein the reversing agent and the procoagulant are included within a cartridge.

45. The system of claim 41 wherein the procoagulant remains within the apparatus.