Apparatus and method for deploying stent across adjacent tissue layers

• US 8,357,193 B2
• Filed: 05/03/2010
• Issued: 01/22/2013
• Est. Priority Date: 05/29/2009
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Xlumena, Inc. (Boston Scientific Corporation)
• Inventors: Phan, Hoang, Lunsford, John, Binmoeller, Kenneth F.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): COBURN, LESLIE ANN
• Application Number:
  US12/772,762
• Publication Number:
  US 20110112622A1
• Time in Patent Office: 995 Days
• Field of Search: 623/1.12, 623 2364- 2367
• US Class Current: 623/1.12
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 17/2909 Handles
• CPC Class Codes: A61B 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202

Abstract

Transluminal access system includes a stent delivery catheter having a handle control mechanism. The catheter comprises a number of components for establishing an initial penetration between adjacent body lumens and subsequently implanting a stent or other luminal anchor therebetween. Manipulation of the stent components is achieved using control mechanisms on the handle while the handle is attached to an endoscope which provides access to a first body lumen.

Claims

1. A method for delivering a stent from a first body lumen, through adjacent opposing luminal walls, to a second body lumen to form an anastomosis, said method comprising:

advancing an endoscope having a working channel to a target site on a wall of the first lumen;

providing a stent deployment apparatus having a control handle and a stent deployment catheter assembly;

advancing at least a portion of the stent deployment catheter assembly into the working channel of the endoscope;

attaching the control handle to the endoscope so that the control handle is immobilized relative to the endoscope;

advancing the stent deployment catheter assembly including a shaft, a self-expanding stent carried on the shaft, and a sheath constraining the stent on the shaft relative to the control handle and the endoscope and through a passage from the first body lumen, through the opposing walls at the target site, and into the second body lumen;

retracting the sheath relative to the endoscope, control handle and shaft by a distance sufficient to release a distal portion of the stent and form a distal flange;

pulling proximally on the stent deployment catheter assembly such that the shaft, the stent and the sheath move simultaneously in the proximal direction to engage the distal flange against the wall of the second body lumen to draw the two luminal walls into closer apposition while a proximal flange of the stent remains constrained by the sheath; and

further retracting the sheath relative to the endoscope, control handle, and shaft to release portions of the stent remaining constrained by the sheath, wherein the proximal flange expands against the wall of the first body lumen.

2. A method as in claim 1, wherein the passage was pre-formed before advancing the stent deployment catheter.

3. A method as in claim 1, further comprising forming the passage by advancing a needle carried by the stent deployment catheter relative to the control handle and the endoscope to penetrate the needle through the opposing walls.

4. A method as in claim 3, wherein the stent deployment catheter is advanced over the needle through the opposing walls after the needle has penetrated said opposing walls.

5. A method as in claim 4, further comprising applying tension to a tension wire which has an anchor in the second body lumen while the stent deployment catheter is advanced over the needle.

6. A method as in claim 5, wherein the tension wire is deployed through an axial passage in the needle.

7. A method as in claim 1, wherein advancing the stent deployment catheter comprises manually advancing a catheter slider on the control handle, wherein the catheter slider is coupled to said catheter assembly to move the shaft, the sheath, and the stent in unison relative to the control handle and endoscope.

8. A method as in claim 7, wherein retracting the sheath comprises manually retracting a collar slider on the control handle, wherein the collar slider is coupled to said sheath to move the sheath relative to the shaft, the stent, the control handle and the endoscope.

9. A method as in claim 3, wherein advancing the needle comprises manually advancing a needle slider on the control handle, wherein the needle slider is coupled to said needle to move said needle relative to the shaft, the stent, the control handle and the endoscope.

10. 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 gallbladder, cysts, pseudocysts, abscesses, the pancreas, the liver, the urinary bladder, duodenum, jejunum, and colon.

11. A method as in claim 1, further comprising a step of locking a proximally pulled position of the deployment catheter assembly relative to the control handle and the endoscope after the step of pulling proximally on the deployment catheter assembly but before the step of further retracting the sheath.