EXPANDABLE ILIAC SHEATH AND METHOD OF USE

• US 20090287182A1
• Filed: 10/24/2008
• Published: 11/19/2009
• Est. Priority Date: 05/14/2008
• Status: Active Grant

• Current Assignee: Terumo Medical Corporation (Terumo Corporation)
• Original Assignee: Onset Medical Corp. (Terumo Corporation)
• Inventors: Bishop, Joseph, Nance, Edward J., Lenker, Jay
• Granted Patent: US 8,668,668 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, small cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system and has utility in the introduction and removal of implant delivery catheters. The access route is through the femoral arteries and the iliac arteries into the aorta. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the arteries into the aorta. The distal end of the sheath is subsequently expanded using a radial dilatation device, which is removed prior to the introduction of implant delivery catheters. In an exemplary application, the sheath includes a supported proximal end, a supported distal end, and a collapsible center section. Certain configurations of the sheath are capable of being inserted in a first, small cross-sectional configuration, being expanded diametrically to a second, larger cross-sectional configuration, and then being reduced to a diametrically small size for removal.

Claims

1. An endovascular intra-aortic catheter for providing access to a patient'"'"'s heart through an aortic passageway leading away from an aortic valve in the patient'"'"'s heart;

the catheter comprising;

a sheath having a distal portion, a proximal portion and a lumen extending therebetween, the proximal portion adapted to extend out of the patient and the distal portion adapted to extend at least to the patient'"'"'s ascending aorta;

the sheath comprising at least one diametrically expandable region that comprises a malleable reinforcement structure configured to maintain the at least one diametrically expandable region in a first cross-sectional configuration in which the at least one diametrically expandable region is longitudinally folded into a reduced cross-sectional profile and can be expanded to a second cross-sectional configuration in which the at least one diametrically expanded region is unfolded into a larger cross-sectional profile; and

a hub coupled to the sheath at its proximal end.

2. The catheter of claim 1, wherein in the first cross-sectional configuration the at least one diametrically expandable region is longitudinally more flexible than in the second cross-sectional configuration.

3. The catheter of claim 1, further comprising a dilator pre-positioned within the sheath.

4. The catheter of claim 1, further comprising a braided reinforcement member on the distal end of the sheath that is configured such that a proximal directed tension on the distal end of the sheath causes axial compression of the braided reinforcement in the sheath wall resulting in diametric expansion of the sheath

5. The catheter of claim 1, further comprising a second expandable region located distally to the first expandable region, wherein the second expandable region is configured to have reduced capability of maintaining its cross-sectional shape relative to the first expandable region.

6. The catheter of claim 5, further comprising a third expandable region located distally to the second expandable region, further wherein the third expandable region is shorter than the second expandable region and has increased capability of maintaining its cross-sectional shape relative to the second expandable region but less capability of maintaining its cross-sectional shape than the first expandable region.

7. The catheter of claim 1, wherein the expandable region comprises an elastic or semi-elastic wall.

8. The catheter of claim 7, wherein the expandable region comprises an elastic or semi-elastic wall further reinforced with an internal braid.

9. The catheter of claim 1, further comprising hemostasis valves at the proximal end of the sheath to prevent excessive loss of blood from the patient.

10. The catheter of claim 1, further comprising a pre-inserted dilator.

11. The catheter of claim 1, further comprising a pre-inserted balloon dilator, wherein the balloon dilator comprises a non-distensible high-pressure balloon disposed along at least the entire length of the expandable region.

12. The catheter of claim 1, wherein the expandable introduction sheath length is sufficient to span the distance from an insertion point in the iliac artery to a region anatomically proximal to the aortic bifurcation.

13. The catheter of claim 1, wherein the expandable region expands from a first, smaller outside diameter of approximately 16 French or less to a second, larger outside diameter of approximately 32 French.

14. The catheter of claim 1, further comprising nitinol reinforcing elements within the expandable region.

15. The catheter of claim 14 wherein the nitinol reinforcing elements are biased to diametrically expand the expandable region.

16. The catheter of claim 14 wherein the nitinol reinforcing elements are biased to diametrically collapse the expandable region.

17. The catheter of claim 14 wherein the nitinol elements comprise shape-memory properties that are fully activated at about body temperature.

18. The catheter of claim 14 wherein the nitinol elements comprise shape-memory elements that are fully activated at temperatures above body temperature.

19. The apparatus of claim 1, wherein the malleable reinforcement structure comprises a flat wire wound into a coil.

20. A method of performing a surgical procedure in a patient'"'"'s vascular system, the method comprising:

advancing a distal portion of a catheter along an aortic passageway towards an aortic valve in a patient'"'"'s heart, the distal portion of the catheter comprising a malleable reinforcing structure longitudinally folded into a reduced cross-sectional profile;

expanding a distal portion of the catheter within an aortic arch of the patient such that the malleable reinforcing structure is unfolded and the distal portion forms to the curve of the aortic arch;

performing therapy or diagnosis through the expanded distal portion of the catheter; and

removing the sheath from the vascular system.

21. The method of claim 20, further comprising advancing a percutaneous valve delivery catheter through the expandable sheath.

22. The method of claim 20, further comprising advancing a percutaneous valve through the expandable sheath.

23. The method of claim 20, further comprising a diametrically expandable delivery system through the sheath, expanding the diametrically expandable delivery system, and delivering a valve prosthesis to a region of the heart through the expanded delivery system.

24. An endovascular introducer catheter for providing access to a patient'"'"'s vascular system;

the catheter comprising;

a sheath having a distal portion, a proximal portion and a lumen extending therebetween, the sheath comprising at least one diametrically expandable region that comprises a malleable reinforcement structure configured to maintain the at least one diametrically expandable region in a first cross-sectional configuration in which the at least one diametrically expandable region is longitudinally folded into a reduced cross-sectional profile and can be expanded to a second cross-sectional configuration in which the at least one diametrically expanded region is unfolded into a larger cross-sectional profile; and

a hub coupled to the sheath at its proximal end.

25. The catheter of claim 24, wherein the sheath comprise a braided reinforcing structure on both the proximal portion and the distal portion of the sheath.

26. The catheter of claim 24 wherein the proximal portion comprises a coil reinforcement fabricated from spring metal.

27. The catheter of claim 24 wherein the proximal portion comprises a coil reinforcement fabricated from spring hardness stainless steel.

28. The catheter of claim 24 wherein the proximal portion comprises both a coil and a braid reinforcement embedded within a polymeric surround.

29. The catheter of claim 24 further comprising a hemostasis valve affixed to the proximal end of the sheath.

30. The catheter of claim 24 wherein the diametrically expandable region comprises a malleable reinforcement structure embedded between two layers of polymer, further wherein the malleable reinforcement structure does not substantially move relative to the two layers of polymer when the sheath is expanded from its first cross-sectional configuration to its second cross-sectional configuration.