Vascular access device

• US 7,025,746 B2
• Filed: 12/24/2002
• Issued: 04/11/2006
• Est. Priority Date: 12/26/2001
• Status: Active Grant

• Current Assignee: Yale University
• Original Assignee: Yale University
• Inventors: Tal, Michael
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): AHMED, AAMER S
• Application Number:
  US10/329,173
• Publication Number:
  US 20030153874A1
• Time in Patent Office: 1,204 Days
• Field of Search: 604/96.01, 604/506, 604/507, 604/510, 604/164.1, 604/110, 604/104, 604/164.08, 604/164.13, 604/523, 604/164.11, 604/168.01, 604/167.01, 604/170.01, 604/104.33, 604/167, 604/170, 60416401-16403, 604/508, 604/97.01
• US Class Current: 604/164.1
• CPC Class Codes: A61M 2025/0687 having means for atraumatic insertion in the body or protection of the tip of the sheath during insertion, e.g. special designs of dilators, needles or sheaths
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/0693 Flashback chambers
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00

Abstract

A vascular access system comprises a needle having a distal tip and a proximal fitting section and a dilator having a solid distal section connected to a solid proximal section and an annular recess therebetween, the dilator having a passageway so that the dilator is coaxially positioned around the needle. The needle has at least one opening positioned proximal to its distal tip so that, when the distal end of the needle enters a blood vessel, blood enters the annular recess to show the operator that access has been achieved. Optionally, a sheath having a distal tip, a proximal fitting section, and a lumen sufficient to coaxially fit over the dilator.

Claims

1. A preassembled vascular access device, the device comprising:

a hollow needle having a bore and a sharpened distal tip and defining a side hole proximal to the distal tip;

a guidewire preloaded in the needle;

a dilator coaxially mounted on the needle thereby defining a first annular space between the dilator and needle, the first annular space communicating with the hollow needle bore through the side hole so that blood, if any, exiting the side hole may flow to the first annular space; and

a sheath coaxially mounted on the dilator thereby defining a second annular space between the sheath and the dilator or between the sheath and the needle;

wherein at least one of the dilator and sheath is clear, semi-opaque, or translucent, so that blood, if any, in at least one of the annular spaces, may be visualized through the dilator and/or sheath to confirm proper placement of the needle in a blood vessel; and

wherein the dilator is slideably displaceable relative to the sheath.

2. A device as defined by claim 1, wherein the sharpened distal tip of the hollow needle protrudes distally from the dilator.

3. A device as defined by claim 2, where the sharpened distal tip of the hollow needle so protrudes distally from the dilator as to reach a central blood vessel of a patient.

4. A device as defined by claim 1, wherein the dilator defines a dilator side hole, and wherein the first annular space communicates with the second annular space through the dilator side hole, so that blood, if any, exiting the dilator side hole may flow to the second annular space.

5. A device as defined by claim 4, wherein the dilator is at least partly semi-opaque, and the sheath is at least partly clear or translucent.

6. A device as defined by claim 1, wherein the dilator and sheath are slideably displaceable together over the needle.

7. A device as defined by claim 1, wherein the needle, dilator, and sheath are slideably displaceable together over the guidewire.

8. A device as defined by claim 1, wherein the dilator is slideably displaceable over the needle to a position in which it covers the needle'"'"'s sharpened distal tip, thereby protecting it.

9. A device as defined by claim 1, wherein the dilator is clear, semi-opaque, or translucent, so that blood, if any, in the first annular space, may be visualized to confirm proper placement of the needle in the blood vessel.

10. A device as defined by claim 1, wherein the sheath is clear, semi-opaque, or translucent, the second annular space communicates with the first annular space, so that blood, if any, in the second annular space, may be visualized to confirm proper placement of the needle in the blood vessel.

11. A device as defined by claim 1, wherein the dilator comprises a discontinuous structure having a solid distal section connected to a solid proximal section by at least one longitudinal member, so that the second annular space is defined between the sheath and the needle and the second annular space communicates with the hollow needle bore through the needle side hole, so that blood, if any, in the second annular space, may be visualized through the sheath to confirm proper placement of the needle in the blood vessel.

12. A device as defined by claim 1, wherein the dilator comprises a continuous tube structure, so that the second annular space is defined between the sheath and the dilator, and so that blood, if any, in the second annular space, may be visualized through the dilator and the sheath to confirm proper placement of the needle in the blood vessel.

13. A device as defined by claim 1, wherein the sheath comprises a side port.

14. A device as defined by claim 1, wherein the hollow needle is so stiff as to support the dilator and sheath during advancement of the device into the blood vessel.

15. A device as defined by claim 1, wherein a distal end of the guidewire is preloaded in the needle, and the guidewire further comprises a proximal free end.

16. A device as defined by claim 1, wherein the dilator comprises a distal dilation section having a double cone configuration.

17. A device as defined by claim 1, wherein the sheath is a peelable sheath.

18. A device as defined by claim 1, further comprising a seal disposed between the dilator and sheath.

19. A device as defined by claim 1, wherein the sheath comprises a hemostatic valve.

20. A device as defined by claim 1, wherein the needle is attached to a proximal needle hub, the dilator is attached to a proximal dilator hub, and the needle hub and dilator hub are interlockable with one another.

21. A device as defined by claim 1, wherein the dilator is affixed to the needle.

22. A method of gaining access to a patient'"'"'s blood vessel, comprising:

providing a preassembled vascular access device, the device comprising;

a hollow needle having a bore and a sharpened distal tip and defining a side hole proximal to the distal tip;

a guidewire preloaded in the needle;

a dilator coaxially mounted on the needle thereby defining a first annular space between the dilator and needle, the first annular space communicating with the hollow needle bore through the side hole so that blood, if any, exiting the side hole may flow to the first annular space; and

a sheath coaxially mounted on the dilator thereby defining a second annular space between the sheath and the dilator or between the sheath and the needle;

introducing the distal tip of the hollow needle into the patient'"'"'s blood vessel;

threading the preloaded guidewire though the distal tip of the needle into the blood vessel;

advancing the dilator and sheath together over the needle into the blood vessel; and

removing the guidewire, the needle, and the dilator, thereby leaving the sheath in place to provide access to the patient'"'"'s blood vessel.

23. A method as defined by claim 22, wherein at least one of the dilator and sheath is clear, semi-opaque, or translucent, so that blood, if any, in at least one of the annular spaces, may be visualized through the dilator and/or sheath, and the method further comprises confirming proper placement of the needle by visualizing blood in at least one of the annular spaces through the dilator and/or sheath.

24. A method as defined by claim 23, wherein the dilator is clear, semi-opaque, or translucent, and the method further comprises confirming proper placement of the needle by visualizing blood in the first annular space.

25. A method as defined by claim 23, wherein the sheath is clear, semi-opaque, or translucent, the second annular space communicates with the first annular space, and the method further comprises confirming proper placement of the needle by visualizing blood in the second annular space through the sheath.

26. A method as defined by claim 23, wherein the dilator comprises a discontinuous structure having a solid distal section connected to a solid proximal section by at least one longitudinal member, so that the second annular space is defined between the sheath and the needle and the second annular space communicates with the hollow needle bore through the side hole, and the method further comprises confirming proper placement of the needle by visualizing blood through the sheath.

27. A method as defined by claim 23, wherein the dilator comprises a continuous tube structure, so that the second annular space is defined between the sheath and the dilator, and the method further comprises confirming proper placement of the needle by visualizing blood through the dilator and sheath.

28. A method as defined by claim 23, wherein proper placement is confirmed, before advancing the dilator and sheath, by observing a blood flash through the dilator and/or sheath.

29. A method as defined by claim 22, wherein the blood vessel is a central blood vessel.

30. A method as defined by claim 29, wherein introducing comprises introducing the distal tip of the hollow needle into the patient'"'"'s central blood vessel without the dilator penetrating the patient'"'"'s skin.

31. A method as defined by claim 22, wherein advancing further comprises advancing the needle together with the dilator and sheath in to the blood vessel over the guidewire.

32. A method as defined by claim 22, wherein the sheath comprises a side port, and the method further comprises sampling the patient'"'"'s blood through the side port.

33. A method as defined by claim 22, further comprising supporting the dilator and sheath with the hollow needle during advancement.

34. A method as defined by claim 22, further comprising observing a blood flash before advancing the dilator and sheath.

35. A method as defined by claim 22, wherein the dilator is so advanced over the needle as to contain the needle distal tip within the dilator to protect the needle distal tip.

36. A preassembled vascular access device, the device comprising:

a hollow needle having a bore and a sharpened distal tip and defining a side hole proximal to the distal tip;

a guidewire preloaded in the needle;

a dilator coaxially mounted on the needle thereby defining a first annular space between the dilator and needle, the first annular space communicating with the hollow needle bore through the side hole so that blood, if any, exiting the side hole may flow to the first annular space, the dilator comprising a distal dilation section having a double cone configuration; and

a sheath coaxially mounted on the dilator thereby defining a second annular space between the sheath and the dilator or between the sheath and the needle;

wherein at least one of the dilator and sheath is clear, semi-opaque, or translucent, so that blood, if any, in at least one of the annular spaces, may be visualized through the dilator and/or sheath to confirm proper placement of the needle in a blood vessel.