Vascular access device

• US 20030153874A1
• Filed: 12/24/2002
• Published: 08/14/2003
• Est. Priority Date: 12/26/2001
• Status: Active Grant

• Current Assignee: Yale University
• Original Assignee: Yale University
• Inventors: Tal, Michael
• Granted Patent: US 7,025,746 B2
• Time in Patent Office: Days
• 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 vascular access system comprising:

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 a recess therebetween, the dilator having a passageway so that the dilator is coaxially positioned around the needle,

wherein the needle has at least one opening positioned proximal to its distal tip and wherein the dilator has a substantially annular recess to receive blood when the distal tip of the needle punctures a vessel.

2. The system of claim 1, wherein the dilator is discontinuous.

3. The system of claim 1, wherein the dilator is clear, semi-opaque, or translucent.

4. The system of claim 1, wherein the dilator has a lateral access to aspirate blood through a syringe.

5. The system of claim 1, wherein the needle and dilator can be advanced together over a guidewire into a blood vessel.

6. The system of claim 5, wherein the guidewire protects the needle from injuring intravascular structures.

7. The system of claim 1, wherein the needle has a lumen and the distal end of a guidewire extends into the needle lumen.

8. The system of claim 1, wherein the possibility of guidewire displacement into a patient'"'"'s vascular system is eliminated.

9. The system of claim 1, wherein the dilator has one or more openings or pores to expel air.

10. The system of claim 1, wherein the dilator has one or more spots of porous material.

11. The system of claim 1, wherein the needle is left on the guidewire to protect the user.

12. The system of claim 1, wherein the needle can be retracted into the dilator and locked in place to protect the blood vessel and, when the dilator needle is removed, the user.

13. The system is claim 1, wherein the dilator has a distally extending distal section.

14. The system of claim 1, wherein the needle proximal section has color coding, wording, or other indicia to indicate the direction of the distal tip bevel.

15. The system of claim 1, wherein the dilator has a distally extending distal section with a distal end to cover the distal tip of the needle.

16. The system of claim 1, wherein after the needle is inserted into the blood vessel, the needle has a function to indicate or lock in place the orientation of the bevel of the needle distal tip.

17. The system of claim 1, wherein a coaxial dilator system with the inner dilator can be extended distally over the needle.

18. A vascular access system comprising:

a needle having a distal tip and a proximal fitting section;

a dilator having a solid distal section connected to a solid proximal section and a recess therebetween, the dilator having a passageway so that the dilator is coaxially positioned around the needle, and;

a sheath having a distal tip, a proximal fitting section and a lumen sufficient to coaxially fit over the dilator,

wherein the needle has at least one opening positioned proximal to its distal tip and wherein the sheath and the dilator form a substantially annular recess to receive blood when the distal tip of the needle punctures a vessel.

19. The system of claim 18, wherein the sheath is clear, semi-opaque, or translucent.

20. The system of claim 18, wherein the dilator is discontinuous.

21. The system of claim 18, wherein the dilator is transparent or semi-opaque.

22. The system of claim 18, wherein the sheath or the dilator has a lateral access to aspirate blood through a syringe.

23. The system of claim 18, wherein the needle, dilator, and sheath are advanced together over a guidewire into a blood vessel.

24. The system of claim 18, wherein the guidewire protects the needle from injuring intravascular structures.

25. The system of claim 18, wherein the dilator or the sheath has one or more openings or pores to expel air.

26. The system of claim 18, wherein the sheath has one or more spots of porous material.

27. The system of claim 18, wherein the needle is left on the guidewire to protect the user.

28. The system of claim 18, wherein the needle can be drawn into the dilator and locked in place to protect the blood vessel when dilator/needle or dilator/needle and sheath is advanced.

29. The system of claim 18, wherein when the guidewire is left in place, the needle can be drawn into the dilator and locked in place to protect the user.

30. The system of claim 18, wherein the dilator has a distally extending distal section with a distal end to cover the distal tip of the needle.

31. The system of claim 18, wherein after the needle is inserted into the blood vessel, the system has a function to indicate or lock in place the orientation of the bevel of the needle distal tip.

32. In a method of introducing a catheter or other medical device into a patient'"'"'s cardiovascular system wherein a needle is introduced into a blood vessel, a guidewire is inserted through the needle into the blood vessel, a dilator is inserted over the guidewire, and a catheter or other medical device is introduced, the improvement wherein the needle and dilator are advanced together over the guidewire.

34. The method of claim 32 or 33, wherein the dilator has a distally extending distal section with a distal end and the dilator is advanced relative to the needle so that the distal end of the dilator distal section is distal to the distal tip of the needle.

35. The method of claim 32 or 33, wherein the dilator in coaxial in shape and has a distally extending inner dilator with a distal end and the inner dilator is advanced relative to the needle so that the distal end of the dilator distal section is distal to the distal tip of the needle.

36. The method of claim 32 or 33, wherein after the needle is inserted into the blood vessel, the needle is rotated to reposition the bevel of the needle distal tip.

37. The method of claim 36, wherein the needle is rotated 180 degrees.

33. In a method of introducing a catheter or other medical device into a patient'"'"'s cardiovascular system wherein a needle is introduced into a blood vessel, a guidewire is inserted through the needle into the blood vessel, a dilator and a sheath are inserted over the guidewire, and a catheter or other medical device is introduced through the sheath, the improvement wherein the needle, dilator, and sheath are advanced together over the guidewire.