Expandable iliac sheath and method of use

• US 9,387,314 B2
• Filed: 09/18/2013
• Issued: 07/12/2016
• 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 A., Nance, Edward J.
• Primary Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US14/030,721
• Publication Number:
  US 20140121670A1
• Time in Patent Office: 1,028 Days
• US Class Current: 1/1
• 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 29/00 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

Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, collapsed cross-sectional configuration, subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration, and subsequent removal in a third, collapsed 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, collapsed cross-sectional configuration during advancement to the arteries into the aorta. The distal end of the sheath is then expanded using a radial dilatation device, which is removed prior to the introduction of implant delivery catheters. The distal end of the sheath is subsequently reduced to a diametrically small size for removal.

Claims

1. A sheath hub for a catheter, the sheath hub comprising:

a housing having a proximal end defining a proximal opening, a distal end defining a distal opening and a chamber disposed therebetween; and

a valve disposed within the chamber, the valve comprising a plurality of valve members, the plurality of valve members configured to control blood leakage through the hub at arterial pressures when nothing is inserted through the chamber up to and including a device that is 26 French in diameter inserted through the chamber;

wherein the housing includes a first port configured for purging and aspirating fluid from the chamber and a second port for infusing into and removing fluid from a jacket configured to collapse a sheath of said sheath hub.

2. The sheath hub of claim 1, wherein the plurality of valve members comprises at least two different types of valves.

3. The sheath hub of claim 1, wherein the plurality of valve members comprises an elastomeric cross-slit valve, and a pair of elastomeric pinhole valves.

4. The sheath hub of claim 1, wherein a spacer is positioned between at least some of the plurality of valve members.

5. The sheath hub of claim 1, further comprising a hub cap coupled to the proximal end of the sheath hub.

6. The sheath hub of claim 1 further comprises a hub cap affixed to the proximal end of the chamber to retain the plurality of elastomeric valves within the chamber.

7. The sheath hub of claim 1, wherein the plurality of valve members comprises at least one elastomeric double convex valve.

8. The sheath hub of claim 7 wherein the elastomeric double convex valve comprises a central orifice.

9. The sheath hub of claim 7 wherein the elastomeric double convex valve comprises at least one slit.

10. The sheath hub of claim 1, wherein the plurality of valve members comprises at least one elastomeric conical taper valve.

11. The sheath hub of claim 10 wherein the elastomeric conical taper valve further comprises a central orifice in a central region.

12. The sheath hub of claim 10 wherein the elastomeric conical taper valve further comprises at least one slit in a central region.

13. The sheath hub of claim 1, wherein the plurality of valve members comprises elastomeric valves.

14. The sheath hub of claim 13 wherein the elastomeric valves comprise silicone elastomer.