Method and apparatus for locating vascular punctures

• US 20050085773A1
• Filed: 10/15/2003
• Published: 04/21/2005
• Est. Priority Date: 10/15/2003
• Status: Abandoned Application

• Current Assignee: St Jude Medical Puerto Rico LLC (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Puerto Rico LLC (Abbott Laboratories Incorporated)
• Inventors: Forsberg, Andrew Thomas
• Application Number:
  US10/686,077
• Publication Number:
  US 20050085773A1
• Time in Patent Office: Days
• US Class Current: 604/164.10
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: A61M 39/28 Clamping means for squeezing flexible tubes, e.g. roller clamps tube strippers A61M1/83

Abstract

The present invention provides vascular insertion sheaths and other tools having penetration locators. The insertion sheaths or other tools also have a switch for controlling fluid flow therethrough. The switch may be a valve or a closed indication chamber that reduces or eliminates blood loss to atmosphere while still providing a visual indication of lumen penetration.

Claims

1. A vascular insertion apparatus, comprising:

a vascular insertion sheath;

a tissue puncture sealing device;

a switch in the vascular insertion sheath, the tissue puncture sealing device, or both for controlling blood flow from a subcutaneous puncture.

2. The vascular insertion apparatus according to claim 1 wherein the switch comprises a visual indication chamber.

3. The vascular insertion apparatus according to claim 2 wherein the visual indication chamber comprises at least one valve for adjusting pressure inside the visual indication chamber.

4. The vascular insertion apparatus according to claim 3 wherein the at least one valve comprises a luer valve.

5. The vascular insertion apparatus according to claim 1 wherein the switch controls blood flow from multiple streams or lumens.

6. The vascular insertion apparatus according to claim 5 wherein the switch comprises one or more luer valves.

7. The vascular insertion apparatus according to claim 1 wherein the switch comprises a push button valve.

8. A vascular insertion apparatus according to claim 7 wherein the push button valve comprises a mandrel with at least one flow passage therethrough, wherein the at least one flow passage is open to the blood flow in an open position and is closed to the blood flow in a closed position.

9. A vascular insertion apparatus according to claim 8 wherein the mandrel further comprises:

a stem extending through a hole in the vascular insertion sheath, the arterial sealing device, or both;

a depressible button at an end of the stem.

10. A vascular insertion apparatus according to claim 9, further comprising a biasing member disposed between the depressible button and the vascular insertion sheath or arterial sealing device, the biasing member biasing the push button valve to the closed position.

11. A vascular insertion apparatus according to claim 9, further comprising at least two flow passages through the push button valve mandrel.

12. A vascular insertion apparatus according to claim 11 wherein the push button valve operates to open or close all of the at least two flow passages through the mandrel.

13. A vascular insertion apparatus according to claim 1 wherein the switch comprises a lever arm and cam.

14. A vascular insertion apparatus, comprising:

a vascular puncture locator;

an insertion sheath receptive of the puncture locator;

a fluid communication path through the puncture locator;

a valve disposed along the fluid communication path for selectively opening and closing the fluid communication path through the puncture locator on demand.

15. A vascular insertion apparatus according to claim 14 wherein the valve comprises a push button valve.

16. A vascular insertion apparatus according to claim 15 wherein the push button valve comprises a mandrel with at least one flow passage therethrough, wherein the at least one flow passage is open to the fluid communication path in an open position and is close to the fluid communication path in a closed position.

17. A vascular insertion apparatus according to claim 16 wherein the mandrel further comprises a stem extending through a hole in the puncture locator and a depressible button at an end of the stem.

18. A vascular insertion apparatus according to claim 17, further comprising a biasing member disposed between the depressible button and the puncture locator.

19. A vascular insertion apparatus according to claim 17 wherein the mandrel further comprises a shoulder disposed opposite of the depressible button and interior to the puncture locator, wherein the shoulder is larger than the hole in the puncture locator.

20. A vascular insertion apparatus according to claim 19 wherein the combination of the depressible button, stem, and shoulder comprises a generally “

I”

shape.

21. A vascular insertion apparatus according to claim 16, further comprising at least two fluid communication paths through the puncture locator.

22. A vascular insertion apparatus according to claim 21 wherein the push button valve operates to open or close all of the at least two fluid communication paths through the puncture locator.

23. A vascular insertion apparatus according to claim 21 further comprising at least one additional valve for each additional fluid communication path through the puncture locator.

24. A vascular insertion apparatus according to claim 14 wherein the fluid communication path comprises at least one tube and the valve comprises a mandrel with a hole therethrough, the at least one tube extending through the hole.

25. A vascular insertion apparatus according to claim 24 wherein the mandrel crimps the at least one tube in a closed position.

26. A vascular insertion apparatus according to claim 14 wherein the valve comprises a lever and cam.

27. A vascular apparatus, comprising:

a vascular insertion sheath having an internal passageway for allowing the passage of vascular instruments or closure devices therethrough, the vascular insertion sheath comprising a switch along a fluid communication path through the sheath for controlling blood flow from a subcutaneous puncture;

wherein the fluid communication path through the sheath is separate from the internal passageway.

28. The vascular apparatus according to claim 27 wherein the switch comprises a visual indication chamber.

29. The vascular insertion apparatus according to claim 28 wherein the visual indication chamber comprises at least one luer valve for adjusting pressure inside the visual indication chamber.

30. The vascular insertion apparatus according to claim 27 wherein the switch controls blood flow from multiple streams or lumens.

31. The vascular insertion apparatus according to claim 27 wherein the switch comprises a push button valve.

32. A vascular insertion assembly, comprising:

an insertion sheath having a distal end, a proximal end, and an inside diameter;

a puncture locator sized to fit in the inside diameter of the insertion sheath, the puncture locator having a distal end and a proximal end;

a first inlet port located at the distal end of the sheath;

a first closed visual indicator in fluid communication with the first inlet port, such that when the first inlet port penetrates a vessel the first indicator provides visual indication without discharging blood to atmosphere.

33. The vascular insertion assembly according to claim 32, further comprising:

a second inlet port located at the puncture locator distal end;

a second closed visual indicator in fluid communication with the second inlet port, such that when the second inlet port penetrates a vessel, the second indicator provides indication without discharging blood to atmosphere.

34. The vascular insertion assembly according to claim 32, wherein the first closed visual indicator is a first drip hole in fluid communication with the first inlet port and enclosed by a chamber.

35. The vascular insertion assembly according to claim 33, wherein the second indicator is a second drip hole in fluid communication with the second inlet port and enclosed by a chamber.

36. A tissue puncture closure device for partial insertion into and sealing of an internal tissue wall puncture, comprising:

a filament extending from a first end of the closure device to a second end of the closure device;

an anchor for insertion through the tissue wall puncture attached to the filament at the second end of the closure device;

a sealing plug slidingly attached to the filament adjacent to the anchor;

a switch for controlling blood flow from the tissue wall puncture through the tissue closure device.

37. The vascular insertion apparatus according to claim 36 wherein the switch comprises a closed visual indication chamber.

38. The vascular insertion apparatus according to claim 37 wherein the visual indication chamber comprises at least one valve for adjusting pressure inside the visual indication chamber.

39. The vascular insertion apparatus according to claim 38 wherein the at least one valve comprises a luer valve.

40. The vascular insertion apparatus according to claim 36 wherein the switch comprises a push button valve.

41. A vascular insertion apparatus according to claim 40 wherein the push button valve comprises a mandrel with at least one flow passage therethrough, wherein the at least one flow passage is open to the blood flow in an open position and is closed to the blood flow in a closed position.

42. A method of controlling blood flow from a vascular insertion apparatus, comprising:

providing a vascular insertion sheath having in internal diameter receptive of a vascular tool and a fluid communication path separate from the internal diameter;

providing a switch disposed along the fluid communication path in the vascular insertion sheath that is selectively operated to permit or restrict blood flow from a subcutaneous puncture through the fluid communication path in the vascular insertion sheath.

43. A method of controlling blood flow from a vascular insertion apparatus according to claim 42 wherein the switch comprises a closed visual indication chamber or a push button valve.

44. The vascular insertion apparatus according to claim 43 wherein the visual indication chamber comprises at least one luer valve for adjusting pressure inside the visual indication chamber.

45. A method of locating a vascular puncture, comprising:

inserting a vascular instrument or insertion sheath into a percutaneous incision;

allowing a flow of blood to enter a fluid passageway disposed in the vascular instrument or insertion sheath;

controlling the flow of blood allowed to enter the fluid passageway;

monitoring a visual indicator of blood flow.

46. A method of locating a vascular puncture according to claim 45 wherein the controlling comprises opening or closing a valve disposed along the fluid passageway.

47. A method of locating a vascular puncture according to claim 46 wherein the monitoring comprises looking for a blood spurt exiting the fluid passageway.

48. A method of locating a vascular puncture according to claim 45 wherein the controlling comprises adjusting pressure within a chamber in fluid communication with the fluid passageway.

49. A method of locating a vascular puncture according to claim 48 wherein the monitoring comprises looking for blood pulsation in the chamber.