Lumen reentry devices and methods

• US 8,721,675 B2
• Filed: 08/24/2012
• Issued: 05/13/2014
• 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:
  US13/594,019
• Publication Number:
  US 20120323269A1
• Time in Patent Office: 627 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 device, such as for use with lumen reentry, including a 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, the catheter and the balloon being sized and shaped for entry between two layers of a wall of a body lumen, wherein upon expansion of the balloon when placed between the layers, 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 balloon catheter for placement between first and second tissue layers of a wall of a blood vessel, the balloon catheter comprising:

a catheter shaft including an outer tubular member and an inner tubular member extending through the outer tubular member; and

a conically shaped balloon having a proximal balloon neck secured to the outer tubular member and an inverted distal balloon neck secured to the inner tubular member;

the conically shaped balloon has a proximal portion tapering radially outward in a distal direction from the proximal balloon neck, and the conically shaped balloon has a distal portion tapering radially outward in a proximal direction from the distal balloon neck, the proximal portion and the distal portion converging at an outermost radial extent of the conically shaped balloon;

wherein in an inflated state the conically shaped balloon has an overall length measured from the proximal balloon neck to the distal balloon neck and a outermost diameter measured at the outermost radial extent, the overall length being less than the outermost diameter.

2. The balloon catheter of claim 1, wherein the proximal portion has a first length and the distal portion has a second length, wherein the first length is greater than the second length.

3. The balloon catheter of claim 2, wherein the first length is less than the outermost diameter of the balloon.

4. The balloon catheter of claim 1, wherein the proximal portion has a first length and the distal portion has a second length, wherein the first length is less than the outermost diameter of the balloon.

5. The balloon catheter of claim 1, wherein the distal end of the inner tubular member does not protrude distally beyond the conically shaped balloon.

6. The balloon catheter of claim 1, wherein the distal end of the inner tubular member protrudes only slightly beyond the conically shaped balloon.

7. The balloon catheter of claim 1, wherein the proximal balloon neck is secured to a distal end of the outer tubular member.

8. The balloon catheter of claim 1, wherein the inverted distal balloon neck is secured to a distal end of the inner tubular member.

9. The balloon catheter of claim 1, wherein a distal portion of the catheter shaft is configured to bend with respect to a proximal portion of the catheter shaft upon expansion of the conically shaped balloon between the first and second tissue layers.

10. The balloon catheter of claim 1, wherein the catheter shaft includes a guidewire lumen defined by the inner tubular member for passage of a guidewire therethrough.

11. The balloon catheter of claim 1, wherein the catheter shaft includes an inflation lumen defined between the inner tubular member and the outer tubular member in fluid communication with the conically shaped balloon.

12. A subintimal re-entry balloon catheter for placement between first and second tissue layers of a wall of a blood vessel to redirect a penetration member into a lumen of the blood vessel, the balloon catheter comprising:

an elongate shaft including an inner tubular member having a guidewire lumen extending therethrough and an outer tubular member surrounding the inner tubular member and defining an inflation lumen between the inner tubular member and the outer tubular member; and

a conically shaped balloon mounted on a distal portion of the elongate shaft, the conically shaped balloon having a proximal balloon neck secured to a distal end of the outer tubular member and an inverted distal balloon neck secured to a distal end of the inner tubular member;

the conically shaped balloon having a proximal portion tapering radially outward in a distal direction from the proximal balloon neck to an outermost radial extent of the balloon and a distal portion tapering radially outward in a proximal direction from the distal balloon neck to the outermost radial extent of the balloon;

wherein in an inflated state the conically shaped balloon has an overall length measured from the proximal balloon neck to the distal balloon neck and a outermost diameter measured at the outermost radial extent, the overall length being less than the outermost diameter; and

wherein the conically shaped balloon is configured such that the distal portion of the elongate shaft is bent relative to a portion of the elongate shaft proximal of the conically shaped balloon when the conically shaped balloon is in the inflated state between the first and second tissue layers such that a distal opening of the guidewire lumen is oriented toward the lumen of the blood vessel.