Expandable iliac sheath and method of use

• US 9,433,766 B2
• Filed: 12/20/2013
• Issued: 09/06/2016
• 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, Lenker, Jay, Nance, Edward J., Nguyen, Huan T., Jones, Mark T.
• Primary Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US14/136,743
• Publication Number:
  US 20140188216A1
• Time in Patent Office: 991 Days
• US Class Current: 1/1
• 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.

Claims

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

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

expanding a distal portion of the sheath 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 sheath; and

removing the sheath from the vascular system;

wherein expanding the distal portion of the sheath comprises expanding the sheath such that a central lumen of the sheath comprises a relatively constant diameter from its distal end to a proximal end of a sheath hub.

2. The method of claim 1, further comprising advancing a percutaneous valve delivery catheter through the expandable sheath.

3. The method of claim 1, further comprising advancing a percutaneous valve through the expandable sheath.

4. The method of claim 1, 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.

5. The method of claim 1, further comprising inserting a dilator within the distal portion of the sheath prior to advancing the distal portion of the sheath.

6. The method of claim 5, wherein the dilator comprises a hollow tube.

7. The method of claim 5, further comprising removing the dilator prior to performing therapy or diagnosis.

8. The method of claim 1, wherein expanding the distal portion of the sheath comprises expanding the distal portion from a first, smaller outside diameter of approximately 16 French or less to a second, larger outside diameter of approximately 32 French.

9. The method of claim 1, further comprising recollapsing the expanded distal portion to a second reduced cross-sectional profile.

10. The method of claim 9, wherein recollapsing the expanded distal portion comprises applying heat to shape-memory reinforcement of the malleable reinforcing structure.

11. The method of claim 9, wherein recollapsing the expanded distal portion comprises compressing the distal portion to a substantially uniform smaller diameter.

12. The method of claim 9, wherein recollapsing the expanded distal portion comprises folding the distal portion into a cross-sectional pattern.

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

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

expanding a distal portion of the sheath 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 sheath; and

removing the sheath from the vascular system;

wherein advancing the distal portion of the sheath comprises advancing the distal portion through a puncture site in the iliac artery to at least the patient'"'"'s aortic arch.

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

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

expanding a distal portion of the sheath 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 sheath;

and

removing the sheath from the vascular system;

wherein expanding the distal portion of the sheath comprises applying a proximal directed tension on the distal portion to cause axial compression of a braided reinforcement of the malleable reinforcement structure.