Lumen reentry devices and methods

• US 8,257,383 B2
• Filed: 03/30/2008
• Issued: 09/04/2012
• Est. Priority Date: 03/29/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Medical Device Limited (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Limited (Boston Scientific Corporation)
• Inventors: Rottenberg, Dan, Zakay, Abi
• Primary Examiner(s): SEVERSON, RYAN J
• Application Number:
  US12/058,715
• Publication Number:
  US 20080243065A1
• Time in Patent Office: 1,619 Days
• Field of Search: 600/184, 600/207, 604/96.01, 604/101.01, 604/101.03, 604/101.05, 606190-192, 606/194, 606/198
• US Class Current: 606/194
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61B 2017/320048 Balloon dissectors
• CPC Class Codes: A61B 2017/320056 Tunnelers
• CPC Class Codes: A61M 2025/0197 for creating an artificial passage within the body, e.g. in order to go around occlusions
• CPC Class Codes: A61M 2025/1065 having a balloon which is inversely attached to the shaft at the distal or proximal end
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A method including introducing a catheter between two layers of a wall of a body lumen, the catheter including a balloon disposed at a distal end thereof, the catheter being formed with a first lumen through the balloon for passing therethrough a guidewire and a second lumen for inflation and deflation of the balloon, and expanding the balloon so that a distal portion of the first lumen that passes through the balloon is bent with respect to a portion of the first lumen proximal to the balloon and is directed towards the body lumen.

Claims

1. A method comprising:

introducing a catheter between first and second layers of a wall of a body lumen, the first layer being radially outward of the second layer, said catheter including a conically shaped balloon disposed at a distal end thereof, the balloon including a proximal tapered portion tapering radially outward in a distal direction from a proximal balloon neck of the balloon to an outermost radial extent of the balloon, said catheter being formed with a first lumen through said balloon for passing therethrough a guidewire and a second lumen for inflation and deflation of said balloon, and wherein the distal end of said catheter does not protrude distally beyond said balloon; and

expanding said balloon between the first and second layers, such that an inner surface of the first layer contacts the balloon along the proximal tapered portion, and wherein expanding the balloon causes a distal portion of said first lumen that passes through said balloon to bend with respect to a portion of said first lumen proximal to said balloon such that the distal portion of said first lumen is directed towards said body lumen.

2. The method according to claim 1, further comprising passing a guidewire through said first lumen and piercing one of said layers to enter said body lumen.

3. The method according to claim 2, wherein said catheter passes between the two layers of the wall of the body lumen adjacent an occlusion in said body lumen, and the method further comprises first introducing said catheter over said guidewire into said body lumen proximal to said occlusion, dissecting the wall of the body lumen with the guidewire near a proximal end of said occlusion, and passing said guidewire through said first lumen and piercing one of said layers to reenter said body lumen distal to said occlusion.

4. A method of revascularizing an occluded blood vessel, the method comprising:

advancing a balloon catheter including a conically shaped balloon mounted on a distal portion of a catheter shaft of the balloon catheter, the balloon including a proximal tapered portion tapering radially outward in a distal direction from a proximal balloon neck of the balloon to an outermost radial extent of the balloon, through a true lumen of the blood vessel to a location proximal of an occlusion, wherein the conically shaped balloon includes a proximal balloon neck secured to a distal end of an outer tubular member of the catheter shaft and an inverted distal balloon neck secured to a distal end of an inner tubular member of the catheter shaft, wherein the distal end of the inner tubular member does not protrude distally beyond the balloon;

inserting a distal portion of the balloon catheter including the conically shaped balloon into a subintimal space dissected between an inner tissue layer and an outer tissue layer of the blood vessel;

advancing the conically shaped balloon in the subintimal space to a location distal of the occlusion;

inflating the conically shaped balloon in the subintimal space at the location distal of the occlusion, such that an inner surface of the outer tissue layer contacts the balloon along the proximal tapered portion, and wherein inflating the conically shaped balloon deflects the inner tissue layer away from the outer tissue layer and automatically bends the distal portion of the balloon catheter toward the true lumen with minimal movement of the outer tissue layer; and

advancing a penetrating member out a distal port of a lumen of the catheter shaft to penetrate through the inner tissue layer into the true lumen distal of the occlusion.

5. The method of claim 4, wherein the penetrating member is a guidewire.

6. The method of claim 4, wherein the penetrating member is a needle-tipped hypotube.

7. The method of claim 4, wherein comprising:

inserting a stent into the subintimal space.