Apparatus and method for deploying stent across adjacent tissue layers

• US 10,321,910 B2
• Filed: 10/21/2016
• Issued: 06/18/2019
• Est. Priority Date: 04/21/2009
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Phan, Hoang, Lunsford, John, Binmoeller, Kenneth F.
• Primary Examiner(s): Lopez, Leslie
• Application Number:
  US15/331,233
• Publication Number:
  US 20170035426A1
• Time in Patent Office: 970 Days
• Field of Search: None
• 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 of draining a second body site to a first body site, comprising:

advancing an endoscope to a location on a wall of the first body site;

creating a lumen in the wall of the first body site and a wall of the second body site;

advancing a deployment assembly through the endoscope and into the lumen, the deployment assembly including a shaft, a self-expanding drainage device carried on the shaft, and a sheath constraining the drainage device;

moving the sheath relative to the shaft a distance sufficient to release a distal flange of the drainage device within the second body site;

withdrawing the shaft, the drainage device and the sheath back together in a proximal direction to engage the distal flange and the second body site in closer apposition with the first body site; and

moving the sheath relative to the shaft to release a proximal flange of the drainage device against the wall of the first body site.

2. The method of claim 1, wherein the self-expanding drainage device is a stent.

3. The method of claim 2, wherein the stent comprises a shape memory material.

4. The method of claim 3, wherein the shape memory material is nitinol and the stent comprises a woven filament braid.

5. The method of claim 4, wherein the woven filament braid comprises multiple filaments or a single filament.

6. The method of claim 2, further comprising an elastomeric material covering the stent.

7. The method of claim 6, wherein, when the proximal flange is released from the sheath, the elastomeric material seals an outer surface of the stent.

8. The method of claim 1, wherein the lumen is created with a penetrating member introduced through the endoscope.

9. The method of claim 8, wherein the penetrating member is a needle that is independent of the deployment assembly.

10. The method of claim 1, wherein a guidewire is introduced into the lumen prior to the deployment assembly advancing step, and the deployment assembly is advanced through the endoscope over the guidewire.

11. The method of claim 1, wherein moving the sheath relative to the shaft comprises retracting the sheath proximally while maintaining a position of the shaft.

12. The method of claim 1, wherein the distance that is sufficient to release the distal flange is predetermined.

13. The method of claim 12, wherein the deployment assembly includes a feature to alert a user to when the predetermined distance is reached.

14. The method of claim 1, wherein the first body site is selected from the group consisting of an esophagus, stomach, duodenum, small intestines, and large intestines, and the second body site is selected from the group consisting of a bile duct, pancreatic duct, gallbladder, cysts, pseudocysts, abscesses, pancreas, liver, urinary bladder, duodenum, jejunum, and colon.

15. The method of claim 14, wherein the first body site is the stomach and the second body site is the pseudocyst.

16. A method for delivering a drainage stent to a target site, the method comprising:

penetrating adjacent tissue layers of a first body lumen and a second body at the target site;

advancing a catheter assembly to the target site, the catheter assembly including a shaft, a sheath slidably disposed over the shaft, and the drainage stent constrained between the shaft and the sheath;

inserting a portion of the catheter assembly into the second body;

moving the sheath relative to the shaft a distance that is less than a length of the drainage stent, such that a portion of the drainage stent becomes unconstrained to deploy a distal flange of the stent in the second body;

drawing the catheter assembly proximally, with the sheath maintained at the distance, to engage the distal flange with the tissue layer of the second body; and

moving the sheath relative to the shaft, such that the remaining portion of the drainage stent becomes unconstrained to deploy a proximal flange of the stent in the first body lumen, whereby the adjacent tissue layers are apposed between the distal flange and the proximal flange.

17. The method of claim 16, wherein the adjacent tissue layer of the first body lumen is selected from the group consisting of an esophagus, stomach, duodenum, small intestines, and large intestines, and the adjacent tissue layer of the second body is selected from the group consisting of a bile duct, pancreatic duct, gallbladder, cysts, pseudocysts, abscesses, pancreas, liver, urinary bladder, duodenum, jejunum, and colon.

18. The method of claim 17, wherein the adjacent tissue layer of the first body lumen is the stomach and the adjacent tissue layer of the second body is the pseudocyst.

19. The method of claim 16, wherein the distance the sheath is moved relative to the shaft is predetermined.

20. The method of claim 19, wherein the catheter assembly includes an indicator to a user when the predetermined distance is reached.