Access Device

• US 20060129100A1
• Filed: 12/21/2005
• Published: 06/15/2006
• Est. Priority Date: 12/26/2001
• Status: Active Grant

• Current Assignee: Yale University
• Original Assignee: Yale University
• Inventors: Tal, Michael
• Granted Patent: US 7,722,567 B2
• Time in Patent Office: Days
• US Class Current: 604/164.100
• 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 device may include a hollow needle, a dilator mounted coaxially on the needle, and a sheath mounted coaxially on the dilator. The dilator may be slideably displaceable relative to the sheath.

Claims

1. A 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 so sized as to be slideable in the needle bore;

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

a sheath coaxially mounted on the dilator, thereby defining a second 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 fluid, if any, in at least one of the spaces, may be visualized through the dilator and/or sheath to confirm proper placement of the needle in a cavity containing the fluid; and

wherein the dilator is slideably displaceable relative to the sheath.

2. The device of claim 1, wherein the sheath is a peel-away sheath.

3. The device of claim 1, wherein the sheath comprises a catheter.

4. The device of claim 3, wherein the catheter is a multi lumen catheter.

5. The device of claim 1, wherein the dilator and sheath are slideably displaceable together over the needle.

6. The device of claim 1, wherein the needle, dilator, and sheath are slideably displaceable together over the guidewire.

7. The device of 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.

8. The device of claim 1, wherein the dilator is clear, semi-opaque, or translucent, so that fluid, if any, in the first space may be visualized to confirm proper placement of the needle in the cavity.

9. The device of claim 1, wherein the sheath is clear, semi-opaque, or translucent, the second space communicates with the first space, so that fluid, if any, in the second space may be visualized to confirm proper placement of the needle in the cavity.

10. The device of 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 space is defined between the sheath and the needle and the second space communicates with the hollow needle bore through the needle side hole, so that fluid, if any, in the second space may be visualized through the sheath to confirm proper placement of the needle in the cavity.

11. The device of claim 1, wherein the dilator comprises a continuous tube structure, so that the second space is defined between the sheath and the dilator, and so that fluid, if any, in the second space may be visualized through the dilator and the sheath to confirm proper placement of the needle in the cavity.

12. The device of claim 1, wherein the sheath comprises a side port.

13. The device of claim 1, wherein the sharpened distal tip of the hollow needle protrudes distally from the dilator.

14. The device of claim 13, wherein the cavity is a central blood vessel of a patient, and the sharpened distal tip of the hollow needle so protrudes distally from the dilator as to reach the central blood vessel of the patient.

15. The device of claim 13, wherein the cavity is a peripheral blood vessel of a patient, and the sharpened distal tip of the hollow needle so protrudes distally from the dilator as to reach the peripheral blood vessel of the patient.

16. The device of claim 1, wherein the hollow needle is so stiff as to support the dilator and sheath during advancement of the device into the cavity.

17. The device of claim 1, wherein the dilator defines a dilator side hole, and wherein the first space communicates with the second space through the dilator side hole, so that fluid, if any, exiting the dilator side hole may flow to the second space.

18. The device of claim 1, wherein the dilator is at least partly semi-opaque, and the sheath is at least partly clear or translucent.

19. The device of claim 1, wherein a distal end of the guidewire is preloaded in the needle, and the guidewire further comprises a proximal free end.

20. The device of claim 1, wherein the dilator comprises a distal dilation section having a double cone configuration.

21. The device of claim 1, further comprising a seal disposed between the dilator and sheath.

22. The device of claim 1, wherein the sheath comprises a hemostatic valve.

23. The device of 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.

24. The device of claim 1, wherein the dilator is attached to a proximal needle hub, the sheath is attached to a proximal sheath hub, and the dilator hub and sheath hub are interlockable with one another.

25. The device of claim 1, wherein the dilator is affixed to the needle.

26. A kit comprising the device of claim 1 and a catheter.

27. The kit of claim 26, wherein the catheter is a central line.

28. The kit of claim 26, wherein the catheter is a peripherally inserted central catheter (PICC).

29. A device comprising:

a hollow needle defining a side hole and having;

a bore so sized as to receive a guidewire; and

a sharpened distal tip distal to the side hole;

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

a sheath coaxially mounted on the dilator, thereby defining a second 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 fluid, if any, in at least one of the spaces, may be visualized through the dilator and/or sheath to confirm proper placement of the needle in a cavity containing the fluid; and

wherein the dilator is slideably displaceable relative to the sheath.

30. A kit comprising the device of claim 29 and a guidewire.

31. The kit of claim 30, further comprising a catheter.

32. A method comprising:

with the device of claim 29, introducing the distal tip of the hollow needle into a cavity;

threading a guidewire through the distal tip of the needle into the cavity;

advancing the dilator and sheath together over the needle into the cavity; and

removing the guidewire, the needle, and the dilator, thereby leaving the sheath in place to provide access to the cavity.

33. The method of claim 32, wherein advancing further comprises

advancing the needle together with the dilator and sheath in to the cavity over the guidewire.

34. The method of claim 32, wherein at least one of the dilator and sheath is clear, semi-opaque, or translucent, so that fluid, if any, in at least one of the first and second spaces, may be visualized through the dilator and/or sheath, and the method further comprises confirming proper placement of the needle by visualizing fluid in at least one of the first and second spaces through the dilator and/or sheath.

35. The method of claim 34, wherein the dilator is clear, semi-opaque, or translucent, and the method further comprises confirming proper placement of the needle by visualizing fluid in the first space.

36. The method of claim 34, wherein the sheath is clear, semi-opaque, or translucent, the second space communicates with the first space, and the method further comprises confirming proper placement of the needle by visualizing fluid in the second space through the sheath.

37. The method of claim 34, 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 space is defined between the sheath and the needle and the second space communicates with the hollow needle bore through the side hole, and the method further comprises confirming proper placement of the needle by visualizing fluid through the sheath.

38. The method of claim 34, wherein the dilator comprises a continuous tube structure, so that the second space is defined between the sheath and the dilator, and the method further comprises confirming proper placement of the needle by visualizing fluid through the dilator and sheath.

39. The method of claim 34, wherein the fluid comprises blood, and proper placement is confirmed, before advancing the dilator and sheath, by observing a blood flash through the dilator and/or sheath.

40. The method of claim 32, wherein the sheath comprises a side port, and the method further comprises sampling fluid from the cavity through the side port.

41. The method of claim 32, wherein the fluid comprises blood.

42. The method of claim 41, wherein the cavity comprises a blood vessel.

43. The method of claim 42, wherein the blood vessel is a central blood vessel.

44. The method of claim 43, 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.

45. The method of claim 41, further comprising observing a blood flash before advancing the dilator and sheath.

46. The method of claim 32, further comprising supporting the dilator and sheath with the hollow needle during advancement.

47. The method of claim 32, 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.

48. The method of claim 32, further comprising advancing a medical device through the sheath.

49. The method of claim 48, wherein the medical device comprises a catheter.

50. The method of claim 49, wherein the cavity is a blood vessel, the fluid is blood, and the medical device comprises a central catheter.

51. The method of claim 50, wherein the central catheter is a peripherally inserted central catheter (PICC).

52. A device comprising:

a hollow needle defining a side hole and having;

a bore so sized as to receive a guidewire; and

a sharpened distal tip distal to the side hole;

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

a sheath coaxially mounted on the dilator;

wherein at least one of the dilator and sheath is clear, semi-opaque, or translucent, so that fluid, if any, inside the device, may be visualized through the dilator and/or sheath to confirm proper placement of the needle in a cavity containing the fluid; and

wherein the dilator is slideably displaceable relative to the sheath.