Clotting cascade initiating apparatus and methods of use and methods of closing wounds

• US 6,159,232 A
• Filed: 12/15/1998
• Issued: 12/12/2000
• Est. Priority Date: 12/16/1997
• Status: Expired due to Term

• Current Assignee: Closys Corporation
• Original Assignee: Closys Corporation
• Inventors: Nowakowski, Karol L.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/212,080
• Time in Patent Office: 728 Days
• Field of Search: 606/213, 606/214, 604/11, 604/19, 604/60
• US Class Current: 606/213
• 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: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00641 for closing fistulae, e.g. anorectal fistulae
• CPC Class Codes: A61B 2017/0065 the implement being an adhesive
• CPC Class Codes: A61L 24/0005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

Wound closure methods and apparatus are provided which utilize blood fluid by activating the clotting cascade of the blood fluid outside the body within a substantially enclosed sterile container then introducing the blood fluid to the wound site to complete clotting. Methods and apparatus for providing ways of inhibiting anticoagulants 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.

Claims

1. A method of closing a wound in a patient, the method comprising the steps of:

a) treating a blood fluid with a procoagulating, agent to initiate a clotting cascade during a first time period such that at least a portion of the blood fluid will form a clot of blood during a second time period subsequent to the first time period, the blood fluid containing sufficient blood components to enable a portion of the blood fluid to clot during the second time period subsequent to the initiation of the clotting cascade during the first time period;

the blood fluid being whole blood; and

b) transporting the treated blood fluid to the wound in the patient such that the blood fluid comes into contact with the patient proximate the wound and the clotting cascade comes generally to a conclusion and a clot forms proximate the wound such that the clot prevents fluid from passing through the wound.

2. The method of claim 1, the step of treating the blood fluid including (1) providing a containment chamber in which the blood fluid can be contained;

(2) placing the blood fluid in the containment chamber; and

(3) initiating the clotting cascade by exposing the blood fluid to a procoagulating agent within the containment chamber.

3. The method of claim 2, the step of treating the blood fluid including providing a substantially enclosed sterile containment chamber, the chamber containing a procoagulating agent.

4. The method of claim 3, wherein the procoagulating agent is a porous matrix and the step of treating the blood fluid includes passing the blood fluid through the porous matrix.

5. The method of claim 4, wherein the porous matrix is biological in origin and the step of treating the blood fluid includes exposing the blood fluid to the biologic material such that the clotting cascade is initiated within the blood fluid.

6. The method of claim 5, wherein the biologic material is a biologic agent is cotton, diatomaceous earth.

7. The method of claim 4, wherein the porous matrix is an inorganic material and the step of treating the blood fluid includes exposing the blood fluid to the inorganic material such that the clotting cascade is initiated within the blood fluid.

8. The method of claim 7, wherein the inorganic material is glass.

9. The method of claim 4, wherein the porous matrix is a synthetic polymer and the step of treating the blood fluid includes exposing the blood fluid to the synthetic polymer such that the clotting cascade is initiated within the blood fluid.

10. The method of claim 9, wherein the synthetic polymer agent is a synthetic polymer selected from the group consisting of dacron, silicone, polyurethane, polycarbonate, polyethylene, polyvinylchloride, polypropylene and nylon.

11. The method of claim 1, further comprising the step of applying direct pressure to an artery proximal to a wound in the artery thereby reducing arterial blood pressure while clot forms in the wound.

12. The method of claim 1, further comprising the step of treating a blood fluid including treatment of the blood fluid with an anticoagulant inhibiting agent.

13. The method of claim 12, the step of treating a blood fluid further including treatment of the blood fluid with an anticlot inhibiting agent.

14. The method of claim 1, the step of treating a blood fluid including treatment of the blood fluid with an anticlot inhibiting agent.

15. A clotting cascade initiation apparatus within which a blood fluid can be received and retained, the blood fluid being useful for treatment of a wound within a patient, said apparatus comprising:

a substantially enclosed sterile containment chamber within which the blood fluid can be received and retained,

the substantially enclosed sterile containment chamber containing a procoagulating agent; and

a cannulated delivery member in fluid communication with the containment chamber such that blood fluid can pass out of the containment chamber and through the cannulated delivery member;

wherein a clotting cascade is initiated when the blood fluid is received in the sterile containment chamber and exposed to the procoagulating agent within the chamber, and subsequently delivered via the cannulated delivery member to the wound subsequent to the initiation of the clotting cascade, such that the clotting cascade, initiated within the sterile containment chamber prior to the delivery of the blood fluid to the wound, can be completed within the wound and a clot can form within the wound when the clotting cascade is completed.

16. The clotting cascade initiation apparatus of claim 15, further including a cannula for delivering blood fluid to the wound, the cannula being in communication with the containment chamber.

17. The clotting cascade initiation apparatus of claim 15, further including a cannula for withdrawing blood fluid from the patient and delivering blood fluid to the wound, the cannula being in communication with the containment chamber.

18. The clotting cascade initiation apparatus of claim 15, wherein the procoagulating agent is a porous matrix through which the blood fluid can be passed.

19. The clotting cascade initiation apparatus of claim 18, wherein the porous matrix is an inorganic material.

20. The clotting cascade initiation apparatus of claim 19, wherein the inorganic material is glass.

21. The clotting cascade initiation apparatus of claim 18, wherein the porous matrix is a synthetic polymer.

22. The clotting cascade initiation apparatus of claim 21, wherein the synthetic polymer is a synthetic polymer selected from the group consisting of dacron, silicone, polyurethane, polycarbonate, polyethylene, polyvinylchloride, polypropylene and nylon.

23. The clotting cascade initiation apparatus of claim 18, wherein the porous matrix is biological in origin.

24. The clotting cascade initiation apparatus of claim 23, wherein the biologic material is a biologic material selected from the group consisting of cotton, diatomaceous earth.

33. The method of claim 15, further comprising the step of applying direct pressure to an artery proximal to a wound in the artery thereby reducing arterial blood pressure while clot forms in the wound.

54. The apparatus of claim 15 or 45, the substantially enclosed sterile containment chamber further containing an anticoagulant inhibiting agent.

55. The apparatus of claim 54;

the substantially enclosed sterile containment chamber further containing an anticlot inhibiting agent.

56. The apparatus of claim 54, wherein the anticoagulant inhibiting agent is an agent selected from the group consisting of catalytic agents and non-catalytic agents.

57. The apparatus of claim 15 or 45;

the substantially enclosed sterile containment chamber further containing an anticlot inhibiting agent.

58. The apparatus of claim 15 or 45;

constituting a kit when when further comprising additional apparatus selected from the group consisting of an introducer, guidewire, dilator, obturator, collapsible catheter sheath, Seldinger needle, balloon catheter, infusion catheter, stent, scalpel, suture line, needle, pouch, tray, tray lid, instructions for use, adhesive identification label and sterility indicator.

25. A method of closing a wound in a patient, said method comprising the steps of:

a) providing a clotting cascade initiation apparatus within which a blood fluid can be received, said apparatus including a substantially enclosed sterile containment chamber within which the blood fluid can be received and retained, and a cannulated delivery member in fluid communication with the containment chamber;

the containment chamber containing a procoagulating agent;

wherein a clotting cascade can be initiated when the blood fluid is placed into the sterile containment chamber and thereby exposed to the procoagulating agent;

b) placing a sufficient amount of blood fluid into the containment chamber to provide a sufficient amount of blood fluid to enable the blood fluid to knit together to form a clot proximate the wound once the clotting cascade is initiated; and

c) delivering the blood fluid to the wound via the cannulated delivery member subsequent to the initiation of the clotting cascade in the containment chamber such that the clotting cascade can be completed and a clot can form within the wound after the blood fluid is delivered to the wound.

26. The method of closing a wound in a patient of claim 25, wherein the procoagulating agent is a porous matrix and the step of placing the blood fluid in the chamber includes passing the blood fluid through the porous matrix.

27. The method of closing a wound in a patient of claim 25, wherein the procoagulating agent is biological in origin.

28. The method of closing a wound in a patient of claim 27, wherein the biologic material is a biologic material selected from the group consisting of cotton, diatomaceous earth.

29. The method of closing a wound in a patient of claim 25, wherein the procoagulating agent is inorganic.

30. The method of closing a wound in a patient of claim 29, wherein the inorganic agent is glass.

31. The method of closing a wound in a patient of claim 25, wherein the procoagulating agent is a synthetic polymer.

32. The method of closing a wound in a patient of claim 31, wherein the synthetic polymer is a synthetic polymer selected from the group consisting of dacron, silicone, polyurethane, polycarbonate, polyethylene, polyvinylchloride, polypropylene and nylon.

59. The method of claim 25, 34, 42, or 44, wherein the step of providing includes providing a substantially enclosed sterile containment chamber containing an anticoagulant inhibiting agent.

60. The methods of claim 25, 34, 42, or 44 wherein the step of providing includes providing a substantially enclosed sterile containment chamber containing an anticlot inhibiting agent.

34. A method of closing a wound in a patient, said method comprising the steps of:

a) providing a clotting cascade initiation apparatus within which a blood fluid can be received and a clotting cascade can be initiated, said apparatus including a substantially enclosed sterile containment chamber within which the blood fluid can be received and retained;

b) placing a sufficient amount of blood fluid into the containment chamber to provide a sufficient amount of blood fluid to enable the blood fluid to knit together to form a clot once the clotting cascade is initiated, the blood fluid being whole blood;

c) placing a procoagulating agent within the substantially enclosed sterile containment chamber such that the procoagulating agent comes into contact with the blood fluid and a clotting cascade is initiated in blood fluid; and

d) delivering the blood fluid to the wound subsequent to the initiation of the clotting cascade in the containment chamber such that the clotting cascade can be completed and a clot can form within the wound.

35. The method of closing a wound in a patient of claim 34, wherein the step of placing the procoagulating agent within the substantially enclosed sterile containment chamber includes placing a biocompatible procoagulating agent within the chamber such that the procoagulating agent is mixed with the blood fluid.

36. The method of closing a wound in a patient of claim 35, wherein the biocompatible procoagulating agent is a biological material.

37. The method of closing a wound in a patient of claim 36, wherein the biological material is a biocompatible procoagulating agent selected from the group consisting of thrombin, collagen, fibrin and fibrinogen.

38. The method of closing a wound in a patient claim 35, wherein the biocompatible procoagulating agent is a synthetic compound.

39. The method of closing a wound in a patient of claim 38, wherein the synthetic biocompatible procoagulating agent is aminocaproic acid.

40. The method of closing a wound in a patient of claim 35, wherein the biocompatible procoagulating agent is an inorganic compound.

41. The method of closing a wound in a patient of claim 35, wherein the inorganic biocompatible procoagulating agent is a salt.

42. A method of closing a wound in a patient, said method comprising the steps of:

a) providing a clotting cascade initiation apparatus within which a blood fluid can be received and a clotting cascade can be initiated, said apparatus including a substantially enclosed sterile containment chamber within which the blood fluid can be received and retained;

b) placing a sufficient amount of blood fluid into the containment chamber to provide a sufficient amount of blood fluid to enable the blood fluid to knit together to form a clot once the clotting cascade is initiated, the blood fluid being whole blood;

c) mechanically stressing the blood fluid within the substantially enclosed sterile containment chamber such that a clotting cascade is initiated in blood fluid, and

d) delivering the blood fluid to the wound subsequent to the initiation of the clotting cascade in the containment chamber such that the clotting cascade can be completed and a clot can form within the wound.

43. The method of closing a wound in a patient of claim 42, wherein the step of mechanically stressing the blood fluid within the substantially enclosed sterile containment chamber is selected from the group consisting of blood fluid agitation, thermal induction and lysis.

44. A method of closing a wound in a patient, said method comprising the steps of:

a) providing a clotting cascade initiation apparatus within which a blood fluid can be received, said apparatus including a substantially enclosed sterile containment chamber within which the blood fluid can be received and retained, and a cannulated delivery member in fluid communication with the containment chamber;

the containment chamber containing a procoagulating agent;

wherein a clotting cascade can be initiated when the blood fluid is placed into the sterile containment chamber and thereby exposed to the procoagulating agent;

b) drawing a sufficient amount of an autologous blood fluid from the patient into the containment chamber to provide a sufficient amount of blood fluid to the wound, once the clotting cascade is initiated, to enable the blood fluid to knit together to form a clot, the blood fluid being whole blood; and

c) delivering the blood fluid to the wound via the cannulated delivery member subsequent to the initiation of the clotting cascade in the containment chamber so that the clotting cascade can be completed and a clot can fonn within the wound after the blood fluid is delivered to the wound.

45. A clotting cascade initiation apparatus within which a blood fluid can be received and retained, the blood fluid being useful for treatment of a wound within a patient, said apparatus comprising:

a substantially enclosed sterile containment chamber within which the blood fluid can be received and retained, the substantially enclosed sterile containment chamber containing a procoagulating agent; and

a cannulated delivery member in fluid communication with the containment chamber such that blood fluid can pass out of the containment chamber and through the cannulated delivery member;

wherein a clotting cascade is initiated when the blood fluid is accepted into the sterile containment chamber and exposed to the procoagulating agent within the chamber, and the blood fluid can be delivered to the wound subsequent to the initiation of the clotting cascade via the cannulated delivery member such that the clotting cascade can be completed proximate the wound and a clot can form proximate the wound when the clotting cascade is completed.

46. A method of closing wound in a patient the method consisting essentially of,

(a) withdrawing an amount of blood fluid from the patient sufficient to form a clot within a wound of sufficient size to prevent fluid from passing through the wound, the blood fluid being whole blood;

(b) exposing the blood fluid to a procoagulating agent to initiate a clotting cascade within the blood fluid; and

(c) subsequently returning the blood fluid to the patient proximate the wound such that the blood fluid, in which the clotting cascade has been initiated, will subsequently clot proximate the wound such that fluid cannot pass through the wound.

47. The method of claim 46, wherein the step of exposing the blood fluid includes exposing the blood fluid to an anticoagulant inhibiting agent.

48. The methods of claims 46 and 47, wherein the step of exposing includes the step of exposing the blood fluid to an anticlot inhibiting agent.

49. The method of claim 47, wherein the anticoagulant inhibiting agent is an inhibiting agent selected from the group consisting of catalytic and non-catalytic inhibiting agents.

50. The method of claim 46, wherein the whole blood contains an anticoagulant.

51. A kit for closing a wound in a patient, the patient containing a blood fluid;

said kit comprising a substantially enclosed sterile containment chamber within which the blood fluid can be received and retained, the substantially enclosed sterile containment chamber containing a procoagulating agent;

wherein a clotting cascade is initiated when the blood fluid is accepted into the sterile containment chamber and exposed to the procoagulating agent within the chamber, and the blood fluid can be delivered to the wound subsequent to the initiation of the clotting cascade such that the clotting cascade can be completed within the wound and a clot can form proximate the wound when the clotting cascade is completed; and

additional apparatus selected from the group consisting of an introducer, guidewire, dilator, obturator, collapsible catheter sheath, Seldinger needle, balloon catheter, infusion catheter, stent, scalpel, suture line, needle, pouch, tray, tray lid, instructions for use, adhesive identification label and sterility indicator.

52. The kit of claim 51;

further comprising a cannulated delivery member in fluid communication with the containment chamber such that blood fluid can pass out of the containment chamber and through the camulated delivery member.

53. The kit of claim 52, wherein the substantially sterile containment chamber contains an agent selected from the group consisting of an anticoagulant inhibiting agent, an anticlot inhibiting agent and a combination thereof.