Method and apparatus for accessing the wall of a vascular structure or other body lumen while simultaneously providing zone isolation and fluid bypass capability

Patent metadata

Field	Value
Publication number	US-9295818-B2
Application number	US-48177609-A
Country	US
Kind code	B2
Filing date	Jun 10, 2009
Priority date	Aug 21, 2008
Publication date	Mar 29, 2016
Grant date	Mar 29, 2016

Abstract

Apparatus and method for accessing the wall of a body lumen while simultaneously providing zone isolation and fluid bypass capability, the apparatus comprising:
an erectable proximal isolation barrier capable of making a sealing engagement with the wall of the body lumen; an erectable distal isolation barrier capable of making a sealing engagement with the wall of the body lumen; a bypass channel secured to, and extending between, the proximal isolation barrier and the distal isolation barrier, the bypass channel comprising a lumen communicating with the region proximal to the proximal isolation barrier and with the region distal to the distal isolation barrier; and a working catheter passing through the proximal isolation barrier and terminating short of the distal isolation barrier, the working catheter providing a central lumen for providing access to the wall of the body lumen between the proximal isolation barrier and the distal isolation barrier.

First claim

What is claimed is:

1. Apparatus for accessing the wall of a body lumen while simultaneously providing zone isolation and fluid bypass capability, the apparatus comprising:
an erectable proximal isolation barrier capable of making a sealing engagement with the wall of the body lumen;
an erectable distal isolation barrier capable of making a sealing engagement with the wall of the body lumen;
a bypass tube secured to, and extending between, the proximal isolation barrier and the distal isolation barrier, the bypass tube comprising a lumen communicating with an area of the body lumen proximal to the proximal isolation barrier and with an area of the body lumen distal to the distal isolation barrier so that fluid may pass from the area of the body lumen proximal to the proximal isolation barrier through the bypass tube to the area of the body lumen distal to the distal isolation barrier;
a working tube being spaced from, and being formed separately from, the bypass tube and passing through the proximal isolation barrier, through the distal isolation barrier, and terminating in the area of the body lumen distal to the distal isolation barrier, the working tube comprising a lumen communicating with an area proximal to the proximal isolation barrier and with the area between the proximal isolation barrier and the distal isolation area, the working tube comprising a slot communicating with the lumen of the working tube, the slot having a length greater than its width and being sized and configured to provide an opening for instruments to pass through in order to access a portion of the wall of the body lumen positioned between the proximal isolation barrier and the distal isolation barrier; and
a guidewire tube being formed separately from the bypass tube and the working tube, the guidewire tube being positioned in the lumen of the working tube so that the guidewire tube extends through the proximal isolation barrier, through the distal isolation barrier, and terminates in the area of the body lumen distal to the distal isolation barrier;
wherein the diameter of the bypass tube is greater than the diameter of the working tube and the diameter of the working tube is greater than the diameter of the guidewire tube.

2. Apparatus according to claim 1 wherein the body lumen comprises a vascular structure.

3. Apparatus according to claim 1 wherein the body lumen comprises one selected from the group consisting of the esophagus, stomach, small or large bowel, ureter, bladder, urethra, bronchus, bile duct, ear, nose and fallopian tube.

4. Apparatus according to claim 1 wherein the erectable proximal isolation barrier and the erectable distal isolation barrier are constructed so as to be capable of assuming a diametrically-reduced configuration and a diametrically-expanded configuration, and further wherein the erectable proximal isolation barrier and the erectable distal isolation barrier are in their diametrically-expanded configuration when making a sealing engagement with the wall of the body lumen.

5. Apparatus according to claim 1 wherein at least one of the erectable proximal isolation barrier and the erectable distal isolation barrier comprises an upstream isolation barrier, and further wherein the upstream isolation barrier is configured to channel blood flow into the bypass tube.

6. Apparatus according to claim 1 wherein the proximal isolation barrier comprises an inflatable/deflatable balloon.

7. Apparatus according to claim 6 wherein the inflatable/deflatable balloon comprises a torus with a membrane closing off its center opening.

8. Apparatus according to claim 6 wherein the proximal isolation barrier comprises a plurality of inflatable/deflatable balloons.

9. Apparatus according to claim 8 wherein the balloons communicate with one another.

10. Apparatus according to claim 1 wherein the proximal isolation barrier comprises a compressible/expandable superelastic shape memory alloy ring.

11. Apparatus according to claim 10 wherein the compressible/expandable superelastic shape memory alloy ring comprises a torus with a membrane closing off its center opening.

12. Apparatus according to claim 1 wherein the distal isolation barrier comprises an inflatable/deflatable balloon.

13. Apparatus according to claim 12 wherein the inflatable/deflatable balloon comprises a torus with a membrane closing off its center opening.

14. Apparatus according to claim 12 wherein the distal isolation barrier comprises a plurality of inflatable/deflatable balloons.

15. Apparatus according to claim 14 wherein the balloons communicate with one another.

16. Apparatus according to claim 1 wherein the distal isolation barrier comprises a compressible/expandable superelastic shape memory alloy ring.

17. Apparatus according to claim 16 wherein the compressible/expandable superelastic shape memory alloy ring comprises a torus with a membrane closing off its center opening.

18. Apparatus according to claim 1 wherein the working tube is releasably secured to the proximal isolation barrier.

19. A method for accessing the wall of a body lumen while simultaneously providing zone isolation and fluid bypass capability, the method comprising:
providing an access system comprising:
an erectable proximal isolation barrier capable of making a sealing engagement with the wall of the body lumen;
an erectable distal isolation barrier capable of making a sealing engagement with the wall of the body lumen;
a bypass tube secured to, and extending between, the proximal isolation barrier and the distal isolation barrier, the bypass tube comprising a lumen communicating with an area of the body lumen proximal to the proximal isolation barrier and with an area of the body lumen distal to the distal isolation barrier so that fluid may pass from the area of the body lumen proximal to the proximal isolation barrier through the bypass tube to the area of the body lumen distal to the distal isolation barrier;
a working tube being spaced from, and being formed separately from, the bypass tube and passing through the proximal isolation barrier, through the distal isolation barrier, and terminating in the area of the body lumen distal to the distal isolation barrier, the working tube comprising a lumen communicating with an area proximal to the proximal isolation barrier and with the area between the proximal isolation barrier and the distal isolation area, the working tube comprising a slot communicating with the lumen of the working tube, the slot having a length greater than its width and being sized and configured to provide an opening for instruments to pass through in order to access a portion of the wall of the body lumen positioned between the proximal isolation barrier and the distal isolation barrier; and

a guidewire tube being formed separately from the bypass tube and the working tube, the guidewire tube being positioned in the lumen of the working tube so that the guidewire tube extends through the proximal isolation barrier, through the distal isolation barrier, and terminates in the area of the body lumen distal to the distal isolation barrier;
wherein the diameter of the bypass tube is greater than the diameter of the working tube and the diameter of the working tube is greater than the diameter of the guidewire tube;
deploying the access system within the body lumen;
erecting the distal isolation barrier and the proximal isolation barrier so that the distal isolation barrier and the proximal isolation barrier make sealing engagements with the wall of the body lumen

Assignees

• Riina Howard
• Milsom Jeffrey
• Cornhill J Fredrick
• Andrews Robert
• Strohl Clair L
• Dickinson Edward L
• Univ Cornell

Inventors

• Riina Howard
• Milsom Jeffrey
• Cornhill J Fredrick
• Andrews Robert
• Strohl Clair L
• Dickinson Edward L

Classifications

• A61B2017/12127

  Double occlusion, e.g. for creating blood-free anastomosis site · CPC title

• A61M2025/1095

  with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft · CPC title

• A61B17/12036

  partial occlusion · CPC title

• A61B17/12136

  Balloons · CPC title

• A61B17/12045

  double occlusion, e.g. during anastomosis · CPC title