Apparatus and methods for reducing bleeding from a cannulation site

• US 20060184199A1
• Filed: 02/14/2005
• Published: 08/17/2006
• Est. Priority Date: 02/14/2005
• Status: Abandoned Application

• Current Assignee: TC1 LLC (Abbott Laboratories)
• Original Assignee: TC1 LLC (Abbott Laboratories)
• Inventors: Werner, Wolfgang, Viole, Anthony, O'Leary, Shawn
• Application Number:
  US11/057,692
• Publication Number:
  US 20060184199A1
• Time in Patent Office: Days
• US Class Current: 606/213
• 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 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61M 2027/004 with at least a part of the circuit outside the body
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202

Abstract

To reduce the risk of hematoma formation, apparatus and methods for reducing bleeding from a cannulation site are provided. In one embodiment, the apparatus comprises a plug that applies pressure to the cannulation site. In another embodiment, the apparatus further comprises a hemostatic agent. In another embodiment, the hemostatic agent is flowable through a lumen of the plug to be deployed at the cannulation site.

Claims

1. An apparatus to reduce or prevent bleeding from a percutaneous cannula insertion site, thereby reducing a risk of hematoma formation, the apparatus comprising:

a cannula having a proximal end and a distal end, the cannula being configured to extend into a blood vessel and provide a path to an interior of the vessel; and

a plug disposed about and at least partially overlapping a portion of the cannula, the plug having a distal end configured to abut an exterior wall of the vessel while the cannula is maintained within the vessel and to reduce or prevent bleeding from the vessel.

2. The apparatus of claim 1, wherein the plug distal end defines a shoulder relative to the cannula.

3. The apparatus of claim 1, further comprising a hemostatic agent applied to the plug distal end, the hemostatic agent configured to further reduce bleeding from the vessel.

4. The apparatus of claim 1, further comprising a hub disposed about a proximal end of the cannula, such that the plug is located distally of the hub.

5. The apparatus of claim 1, wherein the plug is generally tubular.

6. The apparatus of claim 1, wherein at least the plug distal end is constructed of a relatively compliant material.

7. The apparatus of claim 6, wherein a proximal portion of the plug is constructed of a relatively rigid material.

8. The apparatus of claim 1, wherein the plug distal end defines a plane that is not perpendicular to a longitudinal axis of the plug.

9. The apparatus of claim 1, wherein the plug further comprises a first portion having a first exterior dimension, and a second portion having a second, larger, exterior dimension, a distal face of the second portion forming a shoulder with respect to the first portion.

10. The apparatus of claim 9, wherein the shoulder is configured to abut skin in the vicinity of the percutaneous cannula insertion site and apply pressure thereto while the cannula is maintained within the vessel, to thereby reduce or prevent bleeding from the site.

11. An apparatus to reduce or prevent bleeding from a percutaneous cannula insertion site, thereby reducing a risk of hematoma formation, the apparatus comprising:

a cannula configured to extend into a blood vessel and provide a path through a vessel opening to an interior of the vessel;

a plug configured to accept a flow of hemostatic agent therethrough, the plug being disposed about and at least partially overlapping a portion of the cannula, an exterior wall of the cannula and an interior wall of the plug defining an annular space.

12. The apparatus of claim 11, further comprising a hemostatic agent that is configured to flow through the annular space and out of a distal end of the plug.

13. The apparatus of claim 12, wherein the hemostatic agent is configured to promote hemostasis at the vessel opening and/or within tissue surrounding the opening.

14. The apparatus of claim 11, wherein a proximal end of the plug includes an access port.

15. The apparatus of claim 14, wherein the access port comprises a luer connector.

16. The apparatus of claim 11, further comprising a hub disposed about a proximal end of the cannula, such that the plug is located distally of the hub.

17. The apparatus of claim 11, wherein side walls of the plug include at least one aperture.

18. The apparatus of claim 17, wherein the plug side walls include a plurality of apertures.

19. The apparatus of claim 17, further comprising a hemostatic agent that is configured to flow through the annular space and out of the apertures, wherein upon exiting the plug, the hemostatic agent promotes hemostasis at the vessel opening and/or within tissue surrounding the opening.

20. The apparatus of claim 19, wherein a proximal end of the plug includes an access port.

21. A method of reducing or eliminating bleeding from a percutaneous cannula insertion site, thereby reducing a risk of hematoma formation, the method comprising the steps of:

inserting a cannula, having a plug disposed about a portion thereof, into a vessel such that the cannula provides a path through a vessel opening to an interior of the vessel; and

advancing the cannula into the vessel until a distal end of the plug abuts an outer wall of the vessel surrounding the vessel opening.

22. The method of claim 21, wherein a size of the vessel opening is substantially equal to an outer dimension of the cannula, such that the cannula can penetrate the opening but the plug is substantially prevented from penetrating the opening.

23. The method of claim 22, further comprising the step of applying a force along a longitudinal axis of the cannula, such that the plug distal end applies pressure to the vessel outer wall without substantially impairing blood flow downstream of the penetration site.

24. The method of claim 21, wherein the plug distal end includes a hemostatic agent.

25. The method of claim 21, wherein the plug distal end lies in a plane that is not perpendicular to a longitudinal axis of the cannula.

26. A method of reducing or eliminating bleeding from a percutaneous cannula insertion site, thereby reducing a risk of hematoma formation, the method comprising the steps of:

inserting a cannula, having a plug disposed about a portion thereof, an outer surface of the cannula and an inner surface of the plug defining boundaries of an annular space, into a vessel such that the cannula provides a path through a vessel opening to an interior of the vessel

advancing the cannula into the vessel until a distal end of the plug abuts an outer wall of the vessel surrounding the vessel opening; and

injecting a hemostatic agent into the annular space.

27. The method of claim 26, further comprising the step of forcing the hemostatic agent through the annular space such that the hemostatic agent exits the annular space through the plug distal end.

28. The method of claim 27, wherein the plug further includes at least one aperture in a side wall thereof.

29. The method of claim 28, wherein at least a portion of the hemostatic agent exits the annular space through the at least one aperture.

30. The method of claim 26, wherein a proximal end of the plug includes an input port through which the hemostatic agent may be introduced into the annular space.

31. The method of claim 30, wherein the input port comprises a luer connector.

32. The method of claim 26, further comprising the step of withdrawing the plug from the percutaneous cannula insertion site while maintaining the cannula within the vessel opening.

33. The method of claim 32, further comprising the step of forcing the hemostatic agent through the annular space, such that as the plug is withdrawn from the percutaneous cannula insertion site, the hemostatic agent flows through the distal end of the plug to promote hemostasis in tissue surrounding the vessel opening.

34. A medical apparatus comprising:

a cannula configured to extend into a blood vessel through a percutaneous insertion site and provide a path to an interior of the vessel; and

means for reducing bleeding from the insertion site.