System and method for establishing vascular access

• US 6,692,462 B2
• Filed: 12/11/2000
• Issued: 02/17/2004
• Est. Priority Date: 05/19/1999
• Status: Expired due to Fees

• Current Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Original Assignee: InnerDyne, Inc. (Medtronic Plc)
• Inventors: Carlson, John E., Mackenzie, Andrew J.
• Primary Examiner(s): Truong, Kevin T.
• Assistant Examiner(s): DAVIS, DANIEL J
• Application Number:
  US09/735,282
• Publication Number:
  US 20010012946A1
• Time in Patent Office: 1,163 Days
• Field of Search: 606/191, 606/192, 606/194, 606/198, 604/104, 604/107
• US Class Current: 604/104
• 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 the steps of:

inserting an access needle and a plastically deformable, radially expandable sleeve substantially simultaneously 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, wherein the radially expandable sleeve has a compliant or elastic structure so that its cross-section will collapse after expansion;

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

locking said radially expandable sleeve to retain said larger diameter configuration.

2. A method as in claim 1, wherein the step of inserting includes 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 insertion 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 comprises a tubular braid.

7. A method as in claim 6, wherein the tubular braid is a mesh of non-elastic filaments wherein radial expansion causes axial shortening of the braid.

8. A method as in claim 7, wherein the braid is embedded in or covered by an elastic layer.

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

10. 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.).

11. A method for establishing vascular access said method comprising including the steps of:

inserting an access needle and a radially expandable sleeve substantially simultaneously 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, wherein the radially expandable sleeve includes a tubular braid which has a compliant or elastic structure and 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;

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;

removing the dilator wherein the expandable sleeve retains the larger diameter; and

locking the radially expandable sleeve to retain said larger diameter.

12. A method as in claim 11, wherein the step of inserting includes penetrating the needle through tissue overlying the target blood vessel to form the tissue tract.

13. A method as in claim 12, wherein the sleeve is coaxially aligned with the needle so that insertion simultaneously positions both the needle and the sleeve.

14. A method as in claim 13, wherein the tubular braid is a mesh of non-elastic filaments wherein radial expansion causes axial shortening of the braid.

15. A method as in claim 14, wherein the braid is embedded in or covered by an elastic layer.

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

17. A method as in claim 11, wherein the sleeve has a lumen diameter prior to expansion of 0.96 mm (0.038 in.).

18. A method as in claim 17, wherein the dilator has an outside diameter in the range from 1.3 mm to 3.3 mm.

19. A method as in claim 11, wherein the sleeve has a lumen diameter prior to expansion of 0.41 mm (0.016 in.).

20. A method as in claim 19, wherein the dilator has an outside diameter in the range from 1 mm to 2.5 mm.

21. A method for establishing vascular access, said method comprising the steps of:

inserting an access needle and a plastically deformable, radially expandable sleeve substantially simultaneously 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 expandable sleeve to a larger diameter configuration to provide an access lumen to the blood vessel;

providing a locking structure to retain said expandable sleeve in said larger diameter configuration, said locking structure includes a valve disposed within said access lumen of said expandable sleeve;

locking said radially expandable sleeve to retain said larger diameter configuration.

22. The method as in claim 21, wherein said valve of said providing step is a hemostasis valve disposed within said access lumen.

23. The method as in claim 21, wherein said valve of said providing step is a duckbill valve.

24. The method as in claim 21, wherein said valve of said providing step is a miter valve.

25. The method as in claim 21, further including the steps of:

inserting a device through the valve; and

maintaining the valve in an open position when the device is inserted through the valve.

26. A method for establishing vascular access, said method comprising the steps of:

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 expandable sleeve to a larger diameter configuration to provide an access lumen to the blood vessel; and

providing a locking structure to retain said expandable sleeve in said larger diameter configuration, said locking structure including a valve disposed within said access lumen of said expandable sleeve.