System and method for establishing vascular access

• US 20040093003A1
• Filed: 11/05/2003
• Published: 05/13/2004
• Est. Priority Date: 05/19/1999
• Status: Abandoned Application

• Current Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Original Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Inventors: MacKenzie, Andrew J., Carlson, John E.
• Application Number:
  US10/704,073
• Publication Number:
  US 20040093003A1
• Time in Patent Office: Days
• US Class Current: 606/190
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3431 being collapsible, e.g. made of thin flexible material A61B17/3423 takes precedence
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

Systems, kits, and methods for establishing vascular access are described. A system may include a needle, a radially expandable sleeve and a dilator. The methods include creating an initial tissue tract to a target blood vessel with a radially expandable sleeve mounted on a needle. Upon removal of the needle, the dilator is then passed through the radially expandable sleeve to effect radial expansion of the sleeve. Use of the sleeve reduces the risk of injuring tissue surrounding the tissue tract by lessening the axial forces imparted to the tissue. Kits comprise at least the radially expandable sleeve together with instructions for use.

Claims

1. A method for establishing vascular access, said method comprising:

positioning an access needle and a radially expandable sleeve through a percutaneous tissue tract leading to a target blood vessel, so that a distal end of the sleeve lies within the blood vessel and a proximal end of the sleeve lies outside the tissue tract; and

expanding the expansible sleeve to a larger diameter configuration to provide an access lumen to the blood vessel.

2. A method as in claim 1, wherein positioning comprises penetrating the needle through tissue overlying the target blood vessel to form the tissue tract.

3. A method as in claim 2, wherein the sleeve is coaxially aligned with the needle so that penetration simultaneously positions both the needle and the sleeve.

4. A method as in claim 3, wherein the sleeve is coaxially mounted on the needle.

5. A method as in claim 4, wherein the sleeve has an outer diameter which is no more than 300% of the outer diameter of the needle.

6. A method as in claim 1, wherein the radially expandable sleeve has a compliant or elastic structure so that its cross-section will collapse after expansion.

7. A method as in claim 6, wherein the radially expandable sleeve comprises a tubular braid.

8. A method as in claim 7, wherein the tubular braid is a mesh of non-elastic filaments wherein radial expansion causes axial shortening of the braid.

9. A method as in claim 8, wherein the braid is embedded in or covered by an elastic layer.

10. A method as in claim 1, wherein the radially expandable sleeve is plastically deformable or has a locking structure so that it retains its expanded diameter.

11. A method as in claim 1, wherein the radially expandable sleeve comprises an anti-thrombotic coating.

12. A method as in claim 1, wherein the needle has a nominal diameter of 0.92 mm (0.036 in.), and the sleeve has a lumen diameter prior to expansion of 0.96 mm (0.038 in.).

13. A method for establishing vascular access, said method comprising:

positioning an access needle and a radially expandable sleeve through a percutaneous tissue tract leading to a target blood vessel, so that a distal end of the sleeve lies within the blood vessel and a proximal end of the sleeve lies outside the tissue tract;

expanding the expansible sleeve to a larger diameter configuration to provide an access lumen to the blood vessel;

removing the needle from the tissue tract;

introducing a dilator through the expandable sleeve to increase the diameter of the expandable sleeve to a larger diameter; and

removing the dilator wherein the expandable sleeve retains the larger diameter.

14. A method as in claim 13, wherein positioning comprises penetrating the needle through tissue overlying the target blood vessel to form the tissue tract.

15. A method as in claim 14, wherein the sleeve is coaxially aligned with the needle so that penetration simultaneously positions both the needle and the sleeve.

16. A method as in claim 13, wherein the radially expandable sleeve has a compliant or elastic structure, wherein the large diameter of the sleeve is maintained by an outer tube of the dilator which remains in place after the dilator is removed.

17. A method as in claim 16, wherein the radially expandable sleeve comprises a tubular braid.

18. A method as in claim 17, wherein the tubular braid is a mesh of non-elastic filaments wherein radial expansion causes axial shortening of the braid.

19. A method as in claim 18, wherein the braid is embedded in or covered by an elastic layer.

20. A method as in claim 13, wherein the radially expandable sleeve is plastically deformable or has a locking structure so that it retains its larger diameter after the dilator is withdrawn from the lumen of the sleeve.

21. A method as in claim 13, wherein the radially expandable sleeve comprises an anti-thrombotic coating.

22. A method as in claim 13, wherein the sleeve has a lumen diameter prior to expansion of 0.96 mm (0.038 in.).

23. A method as in claim 22, wherein the dilator has an outside diameter in the range from 1.3 mm to 3.3 mm.

24. A method as in claim 13, wherein the sleeve has a lumen diameter prior to expansion of 0.41 mm (0.016 in.).

25. A method as in claim 24, wherein the dilator has an outside diameter in the range from 1 mm to 2.5 mm.

26. A system for establishing vascular access, said system comprising:

an access needle having a pre-selected outer diameter and distal end shaped to penetrate tissue;

a radially expandable sleeve having a lumen therethrough, wherein the sleeve has an unexpanded diameter sized to be coaxially mountable on the access needle and the sleeve is configured to expand to a larger diameter; and

a dilator having an outer diameter sized to be introduceable into the radially expandable sleeve and configured to expand the sleeve to the larger diameter as the dilator is advanced through the lumen of the sleeve.

27. A system as in claim 26, wherein the dilator is tapered at one end to facilitate advancement through the lumen of the radially expandable sleeve.

28. A system as in claim 27, wherein the dilator comprises an outer tube and an inner obturator, wherein the obturator has the tapered end and wherein the obturator is removable from the outer tube so that the tube may be left in place within the radially expandable sleeve after expansion.

29. A system as in claim 28, wherein the radially expandable sleeve has a compliant or elastic structure so that its cross-section will collapse after expansion if the dilator is withdrawn from the lumen of the sleeve.

30. A system as in claim 29, wherein the radially expandable sleeve comprises a tubular braid.

31. A system as in claim 30, wherein the tubular braid is a mesh of non-elastic filaments wherein radial expansion causes axial shortening of the braid.

32. A system as in claim 31, wherein the braid is embedded in or covered by an elastic layer.

33. A system as in claim 26, wherein the radially expandable sleeve is plastically deformable or has a locking structure so that it retains its expanded diameter after the dilator is withdrawn from the lumen of the sleeve.

34. A system as in claim 26, wherein the radially expandable sleeve comprises an anti-thrombotic coating.

35. A system as in claim 26, wherein the access needle has a nominal diameter of 0.92 mm (0.036 in.) and the sleeve has a lumen diameter prior to expansion of 0.96 mm (0.038 in.).

36. A system as in claim 35, wherein the dilator has an outside diameter in the range from 1.3 mm to 3.3 mm.

37. A system as in claim 26, wherein the access needle has a nominal diameter of 0.36 mm (0.014 in.), and the sleeve has a lumen diameter prior to expansion of 0.41 mm (0.016 in.).

38. A system as in claim 37, wherein the dilator has an outside diameter in the range from 1 mm to 2.5 mm.

39. A kit comprising:

a radially expandable sleeve having a lumen therethrough and an unexpanded diameter, said sleeve being configured to be introduced over a guidewire and expand to a larger diameter as a dilator is advanced through the lumen; and

instructions for use setting forth a method of establishing vascular access, said method comprising;

positioning an access needle and the radially expandable sleeve through a percutaneous tissue tract leading to a target blood vessel, so that a distal end of the sleeve lies within the blood vessel and a proximal end of the sleeve lies outside the tissue tract; and

expanding the expansible sleeve to a larger diameter configuration to provide. an access lumen to the blood vessel.

40. A kit as in claim 39, further comprising the access needle having an outer diameter sized for coaxially mounting the sleeve on the access needle.

41. A kit as in claim 40, further comprising a dilator having a outer diameter sized to be introduced into the sleeve.

42. A kit as in claim 41, further comprising a package wherein the sleeve, access catheter and dilator are contained in the package in a sterile condition.

43. A system for establishing vascular access over a guidewire, said system comprising:

a dilator having a lumen sized to be introduced over a guidewire having a pre-selected diameter; and

a radially expandable sleeve having a lumen therethrough and an unexpanded diameter, said sleeve being configured to expand to a larger diameter as the dilator is advanced through the lumen of the sleeve.

44. A system as in claim 43, wherein the dilator is tapered at one end to facilitate advancement through the lumen of the radially expandable sleeve.

45. A system as in claim 44, wherein the dilator comprises an outer tube and an inner obturator, wherein the obturator has the guidewire lumen and the tapered end and wherein the obturator is removable from the outer tube so that the tube may be left in place within the radially expandable sleeve after expansion.

46. A system as in claim 43, wherein the radially expandable sleeve has a compliant or elastic structure so that its cross-section will collapse after expansion if the dilator is withdrawn from the lumen of the sleeve.

47. A system as in claim 46, wherein the radially expandable sleeve comprises a tubular braid.

48. A system as in claim 47, wherein the tubular braid is a mesh of non-elastic filaments wherein radial expansion causes axial shortening of the braid.

49. A system as in claim 48, wherein the braid is embedded in or covered by an elastic layer.

50. A system as in claim 43, wherein the radially expandable sleeve is plastically deformable or has a locking structure so that it retains its expanded diameter after the dilator is withdrawn from the lumen of the sleeve.

51. A system as in claim 43, wherein the radially expandable sleeve comprises an anti-thrombotic coating.

52. A system as in claim 43, further comprising a guidewire.

53. A system as in claim 43, further comprising a sleeve introducer having a tapered distal end and a lumen therethrough, said sleeve introduced being configured to receive a guidewire through its lumen and to be received within the lumen of the sleeve, whereby an assembly of the sleeve and sleeve introducer can be formed so that the tapered end of the sleeve introducer can be advanced through the tissue to facilitate entry.

54. A system as in claim 53, wherein the guidewire has a nominal diameter of 0.89 mm (0.035 in), the dilator has a lumen diameter of 1 mm (0.4 in.), and the sleeve has a lumen diameter prior to expansion of 0.96 mm (0.038 in.).

55. A system as in claim 54, wherein the dilator has an outside diameter in the range from 1.3 mm to 3.3 mm.

56. A system as in claim 53, wherein the guidewire has a nominal diameter of 0.36 mm (0.014 in.), the dilator has a lumen diameter of 0.46 mm (0.018 in.), and the sleeve has a lumen diameter prior to expansion of 0.41 mm (0.016 in.).

57. A system as in claim 56, wherein the dilator has an outside diameter in the range from 1 mm to 2.5 mm.

58. A kit comprising:

a radially expandable sleeve having a lumen therethrough and an unexpanded diameter, said sleeve being configured to be introduced over a guidewire and expand to a larger diameter as a dilator is advanced through the lumen; and

instructions for use according to an improved method for establishing vascular access, said method being of the type wherein a tapered dilator is introduced over a guidewire to enlarge a percutaneous tissue tract, wherein the improvement comprises introducing a radially expandable sleeve over the guidewire prior to introducing the dilator and thereafter introducing the dilator through the sleeve, whereby axial forces on the tissue from the dilator are reduced.

59. A kit as in claim 58, further comprising a dilator having a lumen sized to be introduced over the guidewire.

60. A kit as in claim 59, further comprising the guidewire.

61. A kit as in claim 59, further comprising a sleeve introducer having a tapered distal end and a lumen therethrough, said sleeve introduced being configured to receive a guidewire through its lumen and to be received within the lumen of the sleeve, whereby an assembly of the sleeve and sleeve introducer can be formed so that the tapered end of the sleeve introducer can be advanced through the tissue to facilitate entry.

62. A kit as in claim 59, further comprising a needle.

63. A kit as in claim 59, further comprising a package wherein the sleeve, dilator, and guidewire are contained in the package in a sterile condition.