Expandable iliac sheath and method of use

• US 8,562,559 B2
• Filed: 11/12/2010
• Issued: 10/22/2013
• Est. Priority Date: 05/14/2008
• Status: Active Grant

• Current Assignee: Terumo Medical Corporation (Terumo Corporation)
• Original Assignee: Onset Medical Corp. (Terumo Corporation)
• Inventors: Lenker, Jay, Nance, Edward J., Bishop, Joseph
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Eisenberg, Rebecca E
• Application Number:
  US12/945,801
• Publication Number:
  US 20110152763A1
• Time in Patent Office: 1,075 Days
• Field of Search: 604/509, 604/101.01, 60410301-10314, 604/96.01, 604/99.04, 604/264, 604/274, 604/270
• US Class Current: 604/103.06
• 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. An intra-aortic catheter, comprising:

a first elongate member comprising a proximal portion, a collapsible distal portion, and a lumen extending through the proximal portion and the collapsible distal portion;

a second elongate member comprising a proximal end, a distal end, and a lumen between the proximal end and the distal end, the lumen of the second elongate member comprising a chamber, the collapsible distal portion of the first elongate member positioned within the lumen of the second elongate member; and

a dilator positioned within the lumen of the first elongate member, the dilator configured to expand the collapsible distal portion of the first elongate member from a first, collapsed cross-sectional configuration to a second, expanded cross-sectional configuration;

wherein the chamber of the second elongate member is configured to, when pressurized, collapse the collapsible distal portion of the first elongate member from the second, expanded cross-sectional configuration to a third, collapsed cross-sectional configuration, the collapsible distal portion of the first elongate member having an outer diameter smaller in the third, collapsed cross-sectional configuration than in the second, expanded cross-sectional configuration.

2. The catheter of claim 1, wherein at least a portion of the collapsible distal portion of the first elongate member is positioned adjacent to the chamber of the second elongate member.

3. The catheter of claim 1, wherein at least a portion of the collapsible distal portion of the first elongate member is positioned within the chamber of the second elongate member.

4. The catheter of claim 3, wherein the distal end of the second elongate member is bonded to the collapsible distal portion of the first elongate member.

5. The catheter of claim 4, wherein the distal end of the second elongate member is folded over a distal end of the first elongate member and coupled to an inner surface of the first elongate member.

6. The catheter of claim 4, wherein the distal end of the second elongate member is folded over a distal end of the first elongate member and coupled between an inner surface and outer surface of the first elongate member.

7. The catheter of claim 4, wherein the proximal end of the second elongate member is bonded to the proximal portion of the first elongate member.

8. The catheter of claim 1, wherein the collapsible distal portion comprises one or more longitudinal folds when in the first, collapsed cross-sectional configuration.

9. The catheter of claim 8, wherein the one or more longitudinal folds comprise two outside edges and two inside edges which form longitudinal creases.

10. The catheter of claim 1, wherein the first elongate member further comprises a malleable reinforcement embedded in at least a portion of the collapsible distal portion.

11. The catheter of claim 10, wherein the malleable reinforcement is configured to:

reform in response to expansion of the dilator;

reform in response to pressurization of the chamber of the second elongate member; and

maintain the collapsible distal portion in each of the first, collapsed cross-sectional configuration, the second, enlarged cross-sectional configuration, and the third, collapsed cross-sectional configuration.

12. The catheter of claim 11, wherein the malleable reinforcement is a metal coil.

13. The catheter of claim 1, wherein the first, collapsed cross-sectional configuration and the third, collapsed cross-sectional configuration have a substantially similar diameter.

14. The catheter of claim 1, wherein the dilator comprises a balloon dilator.

15. The catheter of claim 1, wherein the first elongate member further comprises a sheath hub at a proximal end of the first elongate member, the sheath hub comprising a port operably connected to the chamber of the second elongate member.

16. The catheter of claim 15, wherein the dilator comprises a dilator hub at a proximal end of the dilator, the dilator hub releasably coupled to the sheath hub.

17. The catheter of claim 1, wherein the dilator comprises a distal fairing configured to cover a distal edge of the first elongate member.

18. An intra-aortic catheter, comprising:

a first elongate member comprising a lumen;

a second elongate member comprising one or more vents and a distal balloon positioned distal to the one or more vents; and

a hub comprising a first port and a second port;

wherein the second elongate member is configured to be positioned within the lumen of the first elongate member;

wherein the distal balloon is configured, when expanded, to form a seal with an inside surface of the first elongate member such that a gap is created in the lumen of the first elongate member between an inner surface of the first elongate member and an outer surface of the second elongate member, the gap positioned proximal to the distal balloon; and

wherein the first port is operably connected to the one or more vents to evacuate the gap to deflate the first elongate member, and the second port is operably connected to the distal balloon to allow the distal balloon to remain substantially expanded when the gap is being evacuated.

19. The catheter of claim 18, wherein the second elongate member further comprises a proximal balloon positioned proximal to the one or more vents, wherein the proximal balloon is configured, when expanded, to form a seal with an inside surface of the first elongate member proximal to the gap.