Lumen reentry devices and methods

• US 8,257,382 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:
  US12/058,714
• Publication Number:
  US 20080243067A1
• 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 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 device comprising:

a catheter comprising a conically shaped balloon disposed at a distal end thereof, 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, said catheter and said balloon being sized and shaped for entry between two layers of a wall of a body lumen, wherein a proximal portion of the balloon tapers radially outward in a distal direction from a proximal balloon neck of the balloon to an outermost radial extent of the balloon and a distal portion of the balloon tapers radially outward in a proximal direction from a distal balloon neck of the balloon to the outermost radial extent of the balloon, wherein the proximal portion has a first length and the distal portion has a second length, wherein the first length is longer than the second length and the first length is smaller than a maximum diameter of said balloon, wherein upon expansion of said balloon when placed between said layers, a distal portion of said first lumen that passes through said balloon is automatically bent with respect to a portion of said first lumen proximal to said balloon and is directed towards said body lumen, wherein the distal end of said catheter does not protrude distally beyond said balloon.

2. The device according to claim 1, wherein said balloon comprises an inverted distal neck and the distal end of said catheter is secured to said inverted distal neck.

3. The device according to claim 1, further comprising a guidewire that passes through said first lumen and which is adapted to pierce at least one of the layers to enter said body lumen.

4. The device according to claim 1, further comprising a hypo-tube needle disposed in said first lumen and a guidewire that passes through an internal cavity of said needle, a distal end of said needle being adapted to pierce at least one of the layers to enter said body lumen.

5. The device according to claim 1, wherein a diameter of said balloon is so dimensioned as to be not more than a diameter of said body lumen.

6. The device according to claim 1, wherein said catheter is formed with a pivoting portion proximal to the distal portion upon which said balloon is disposed.

7. The device according to claim 6, wherein said pivoting portion comprises a weakened section having a smaller wall thickness than other portions of said catheter.

8. The device according to claim 6, wherein said pivoting portion comprises a portion made of a flexible material.

9. The device according to claim 6, wherein said pivoting portion comprises a joint.

10. The device according to claim 6, wherein said pivoting portion comprises a section which is softer and easier to bend than the rest of said catheter.

11. The device according to claim 1, wherein a diameter of said balloon is so dimensioned as to be equal to or slightly larger than a diameter of said body lumen.

12. The device according to claim 1, further comprising a second balloon mounted on said catheter proximal to said balloon, said second balloon being inflatable through a third lumen formed in said catheter.

13. A device comprising:

a catheter comprising a conically shaped balloon disposed at a distal end thereof, 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, said catheter and said balloon being sized and shaped for entry between two layers of a wall of a body lumen, wherein a proximal portion of the balloon tapers radially outward in a distal direction from a proximal balloon neck of the balloon to an outermost radial extent of the balloon and a distal portion of the balloon tapers radially outward in a proximal direction from a distal balloon neck of the balloon to the outermost radial extent of the balloon, wherein the proximal portion has a first length and the distal portion has a second length, wherein the first length is longer than the second length and the first length is smaller than a maximum diameter of said balloon, wherein upon expansion of said balloon when placed between said layers, a distal portion of said first lumen that passes through said balloon is bent with respect to a portion of said first lumen proximal to said balloon and is directed towards said body lumen, wherein the distal end of said catheter protrudes only slightly, or does not protrude at all, beyond said balloon;

wherein said catheter is slidingly disposed in a sheath and the distal portion of said catheter is bendable at a juncture with a distal end of said sheath.

14. A balloon catheter for use in reentry into a true lumen of a blood vessel from a subintimal space, the balloon catheter comprising:

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

a conically shaped balloon mounted on a distal portion of the elongate shaft, the conically shaped balloon including 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;

wherein the balloon includes an outermost radial extent, wherein a proximal portion of the balloon tapers radially outward in a distal direction from the proximal balloon neck to the outermost radial extent and a distal portion of the balloon tapers radially outward in a proximal direction from the distal balloon neck to the outermost radial extent, wherein the proximal portion has a first length and the distal portion has a second length, wherein the first length is longer than the second length and the first length is smaller than a maximum diameter of said balloon;

wherein an inflation lumen defined between the inner tubular member and the outer tubular member is in fluid communication with an interior of the conically shaped balloon;

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 as the conically shaped balloon is inflated in a subintimal space defined between adjacent tissue layers of a wall of a blood vessel.

15. The balloon catheter of claim 14, wherein the distal end of the inner tubular member does not protrude distally beyond the conically shaped balloon.

16. The balloon catheter of claim 15, wherein a length of the conically shaped balloon is not more than a diameter of the conically shaped balloon.