Occlusion sheath for imaging catheter

Patent metadata

Field	Value
Publication number	US-2016144155-A1
Application number	US-201414899877-A
Country	US
Kind code	A1
Filing date	Jul 1, 2014
Priority date	Jul 1, 2013
Publication date	May 26, 2016
Grant date	—

Abstract

An occlusion sheath having an expandable member is described herein. The occlusion sheath is configured to occlude or limit blood flow to a vessel while providing a central lumen to allow a catheter, such as an imaging catheter and/or an atherectomy catheter, to travel therethrough.

First claim

1 . An occlusion sheath, comprising:
an outer elongate member; an inner elongate member extending within the outer elongate member; a central lumen within the inner elongate member, the central lumen having a diameter of greater than 0.055 inches and configured to accommodate a catheter; and an occlusion balloon attached to the outer elongate member and configured to expand to occlude or reduce the flow through a vessel.

2 . The occlusion sheath of claim 1 , wherein a proximal end of the balloon is sealed against the outer elongate member, and wherein a distal end of the balloon is sealed against the outer elongate member or the inner elongate member.

3 . The occlusion sheath of claim 1 , wherein an annular inflation lumen is formed between the outer elongate member and the inner elongate member, the inflation lumen in communication with the balloon.

4 . The occlusion sheath of claim 3 , further comprising a hole through the outer elongate member between the proximal end of the balloon and the distal end of the balloon to allow communication between the inflation lumen and the balloon.

5 . The occlusion sheath of claim 4 , wherein the hole is positioned closer to a proximal end of the balloon than a distal end of the balloon.

6 . The occlusion sheath of claim 1 , wherein the sheath further comprises a tapered tip.

7 . The occlusion sheath of claim 6 , wherein the tapered tip is attached to the outer elongate member with a lap joint.

8 . The occlusion sheath of claim 6 , wherein the tapered tip is radiopaque.

9 . The occlusion sheath of claim 1 , wherein an outer diameter of the balloon when fully inflated and unconstrained is 4-20 mm.

10 . The occlusion sheath of claim 1 , wherein an outer diameter of the outer elongate tube is less than 0.165 inches in diameter.

11 . The occlusion sheath of claim 1 , further comprising a radiopaque marker configured to indicate a position of the balloon.

12 . The occlusion sheath of claim 1 , further comprising a hub attached to the inner and outer elongate members, the hub including a first port for passage of the catheter and a second port for passage of air or fluid to inflate the balloon.

13 . The occlusion sheath of claim 1 , wherein the catheter is an atherectomy catheter.

14 . The occlusion sheath of claim 1 , wherein the catheter is an imaging catheter.

15 . A method of performing atherectomy within a vessel, comprising:
inserting an occlusion sheath into a vessel; inserting an atherectomy catheter having an imaging sensor and a cutter through a central lumen of the occlusion sheath; inflating a balloon of the occlusion sheath to reduce the flow through the vessel; imaging the vessel with the imaging sensor while the vessel flow is reduced; and cutting tissue inside the vessel with the cutter.

16 . The method of claim 15 , wherein inflating the balloon comprises injecting fluid or air into an annular space between an inner and outer elongate member of the occlusion sheath such that the fluid or air flows down the annular space and into the balloon.

17 . The method of claim 15 , wherein imaging comprises imaging with optical coherence tomography.

18 . The method of claim 15 , further comprising placing an introducer through the central lumen of the occlusion sheath prior to inserting the occlusion sheath such that a distal taper of the inserter extends out a distal end of the occlusion sheath.

19 . The method of claim 15 , wherein cutting the tissue comprises cutting tissue while the vessel is occluded.

20 . The method of claim 15 , wherein the balloon is inflated for 20-30 minutes.

21 . The method of claim 15 , further comprising deflating the balloon after cutting to resume blood flow through the vessel and then repeating the inflating, imaging, and cutting steps.

22 . An occlusion sheath, comprising:
an elongate member; a central lumen within the elongate member configured to accommodate a catheter; an occlusion balloon attached to the elongate member and configured to expand to occlude a vessel; and a sealing mechanism within the central lumen and distal to a proximal end of the occlusion balloon, the sealing mechanism configured to seal against the catheter when the catheter is within the central lumen such that a balloon inflation lumen is formed between an outer surface of the catheter and an inner surface of the elongate member.

23 . The occlusion sheath of claim 22 , wherein the sealing mechanism is an annular lip.

24 . The occlusion sheath of claim 22 , wherein the catheter is an atherectomy catheter.

25 . The occlusion sheath of claim 22 , wherein the catheter is an imaging catheter.

Assignees

• Avinger Inc

Inventors

• Simpson John B
• Ketai Theodore W
• Askew Mark W
• Loh Serena S
• Nguyen Guip T
• Davies Stephen C
• Newhauser Richard R
• Smith Peter H

Classifications

• A61B5/0066

  Optical coherence imaging · CPC title

• A61M2025/109

  having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow · CPC title

• A61M2025/1052

  for temporarily occluding a vessel for isolating a sector · CPC title

• A61B17/3207

  Atherectomy devices {working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions (A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016)} · CPC title

• A61M2025/1081

  having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths · CPC title