METHODS AND SYSTEMS FOR PENETRATING ADJACENT TISSUE LAYERS

• US 20110137394A1
• Filed: 05/28/2010
• Published: 06/09/2011
• Est. Priority Date: 05/29/2009
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Xlumena, Inc. (Boston Scientific Corporation)
• Inventors: Lunsford, John, Binmoeller, Kenneth F.
• Application Number:
  US12/790,553
• Publication Number:
  US 20110137394A1
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/1103 Approximator
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections

Abstract

Penetration and dilation of passages from a first body lumen to a second body lumen are achieved while providing tension anchoring of the luminal walls to inhibit the leakage of body fluids. In one embodiment, one or more T-bar anchors may be used to provide the tensioning of the body lumen walls. In a second embodiment, a plurality of hooked or everted wires may be provided on a catheter which is used to penetrate and dilate a passage between the luminal walls.

Claims

1. A method for advancing a dilator distally through apposed luminal walls of adjacent first and second body lumens at a target site on an anterior surface of a first luminal wall, said method comprising:

deploying a tension anchor through the apposed luminal walls at a location laterally offset from the target site;

drawing the tension anchor proximally to hold a posterior surface of the first luminal wall against an anterior surface of a second luminal wall; and

advancing the dilator through the walls at the target site while continuing to hold the luminal wall surfaces together, wherein the dilator creates an enlarged passage.

2. A method as in claim 1, wherein the first body lumen is selected from the group consisting of the esophagus, the stomach, the duodenum, the small intestines, and the large intestines and the second body lumen is selected from the bile duct, the pancreatic duct, the gall bladder, cysts, pseudocysts, abscesses, the pancreas, the liver, the urinary bladder, duodenum, jejunum, and colon.

3. A method as in claim 1, wherein deploying comprises advancing a tether having a self-deploying anchor from the first body lumen, through the apposed luminal walls at the laterally offset location, and into the second body lumen, wherein the anchor self-deploys as tension is applied to the tether.

4. A method as in claim 3, wherein the tether having a self-deploying anchor comprises a T-bar anchor.

5. A method as in claim 4, wherein the T-bar anchor is initially disposed in a hollow needle, the needle is advanced from the first body lumen into the second body lumen, the T-bar anchor released from the needle to deploy in the second body lumen, and the needle withdrawn through the luminal walls.

6. A method as in claim 1, wherein deploying comprises positioning a distal end of a catheter through the first body lumen at the target site and advancing the tension anchor from the catheter through the apposed luminal walls.

7. A method as in claim 6, wherein a plurality of anchors are advanced from the catheter through the apposed luminal walls.

8. A method as in claim 6, wherein the anchor comprises a wire having a pre-shaped distal end, wherein the wire is advanced from an axial passage on the catheter so that the distal end assumes its shape upon entering the second body lumen and engages a posterior surface of the second luminal wall.

9. A method as in claim 6, wherein an access needle is advanced from a central passage of the catheter through the apposed luminal walls.

10. A method as in claim 9, wherein the access needle is advanced prior to advancing the tension anchor.

11. A method as in claim 9, wherein the access needle is advanced after advancing the tension anchor.

12. A method as in claim 9, wherein the dilator is advanced over the access needle to enlarge the passage through the apposed luminal walls.

13. A method as in claim 12, wherein the dilator has a cutting or electrosurgical tip.

14. A method as in claim 1, further comprising releasing a self-expanding stent within the enlarged passage.

15. A method as in claim 14, wherein the stent holds the first and second luminal walls together.

16. A method as in claim 14, wherein the stent is released from the dilator after the passage has been enlarged.

17. An apparatus for dilating a passage through apposed luminal walls, said apparatus comprising:

a catheter having a proximal end, a distal end, and a central passage therethrough;

a needle having a tissue penetrating distal tip, said needle being reciprocatably mounted in the central passage of the catheter so that the tissue penetrating distal tip can be advanced beyond said distal tip to penetrate the apposed luminal walls;

a dilator slidably mounted over the needle so that the dilator can be advanced to dilate the penetration formed by the needle through the apposed luminal walls; and

a tension anchor reciprocatably mounted on the catheter to penetrate a tissue location which is laterally offset from the dilator penetration location.

18. An apparatus as in claim 17, wherein the tension anchor is disposed in a peripheral lumen of the catheter.

19. An apparatus as in claim 18, comprising a plurality of tension anchors, wherein each tension anchor is disposed in a separate peripheral lumen of the catheter.

20. An apparatus as in claim 18, wherein the tension anchor comprises a wire having a pre-shaped distal end that is straightened when held in the peripheral lumen and which everts radially outwardly when it emerges from the peripheral lumen to hook into and engage the luminal walls.

21. An apparatus as in claim 17, wherein the dilator comprises a shaft having a tapered dilating tip at its distal end.

22. An apparatus as in claim 21, wherein the tapered dilating tip has a sharpened blade to cut tissue as it is advanced through the luminal walls.

23. An apparatus as in claim 21, further comprising a self-expanding stent carried on the dilator shaft proximal of the tapered distal tip, where said stent is constrained within a retractable tubular sheath.