APPARATUS AND METHOD FOR DEPLOYING STENT ACROSS ADJACENT TISSUE LAYERS

• US 20110112622A1
• Filed: 05/03/2010
• Published: 05/12/2011
• 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.
• Granted Patent: US 8,357,193 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• 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 luminal walls, to a second body lumen, said method comprising:

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

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

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

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

pulling proximally on the stent deployment assembly to engage the distal flange against the wall of the second body lumen to draw the two luminal walls into closer apposition; and

further retracting the sheath relative to the endoscope, handle, and shaft to release the remaining portions of the stent within the passage, wherein a 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 handle and the endoscope to penetrate the needle through the apposed luminal walls.

4. A method as in claim 3, wherein the stent deployment catheter is advanced over the needle through the apposed walls after the needle has penetrated said apposed 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 handle, wherein the catheter slider is coupled to said catheter assembly to move the shaft, sheath, and stent in unison relative to the handle and endoscope.

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

9. A method as in claim 8, wherein advancing the needle comprises manually advancing a needle slider on the handle, wherein the needle slider is coupled to said needle to move said needle relative to the shaft, stent, handle and 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 for delivering a stent from a first body lumen through adjacent walls to a second body lumen, said method comprising:

positioning an endoscope in the first body lumen adjacent to a target site on a luminal wall;

advancing a catheter assembly in a working channel of the endoscope to locate a distal region of the catheter assembly at the target site;

penetrating a needle carried by the catheter assembly through the apposed walls at the target site;

deploying an anchor on a distal end of a tension wire in the second body lumen;

drawing proximally on the tension wire to maintain the walls in close apposition;

advancing a stent deployment sub-assembly which carries the stent over the needle while maintaining tension on the tension wire;

expanding a distal flange on the stent in the second body lumen;

drawing proximally on the stent deployment sub-assembly to pull the distal flange against the wall of the second body lumen to maintain the walls in apposition; and

expanding a proximal flange on the stent in the first body lumen to complete delivery.

12. A method as in claim 11, wherein deploying the anchor comprises advancing the tension wire through an axial passage of the needle after the needle has penetrated through the apposed walls.

13. A method as in claim 12, wherein the anchor is a self-expanding structure formed integrally with the tension wire.

14. A method as in claim 11, wherein the self-expanding anchor structure deploys as the tension wire is advanced from the needle causing the anchor to be released from the axial passage of the needle and to cover a distal tip of the needle.

15. A method as in claim 14, wherein the self-expanding structure comprises a plurality of loops which deploy rearwardly to form a concave structure over the wall of the second body lumen, wherein the concave structure provides clearance for advancing the stent deployment sub-assembly.

16. A method as in claim 11, wherein the stent is self-expanding and is deployed by retracting a sheath which is part of the stent deployment sub-assembly.

17. A method as in claim 16, wherein the sheath is sequentially retracted to first deploy the distal flange and, after drawing the distal flange against the wall of the second body lumen, the sheath is further refracted to deploy the proximal flange.

18. A method as in claim 11, wherein the first body lumen is selected from the group consisting of the esophagus, the stomach, the duodenum, the small intestines, 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.

19. Apparatus for delivering a self-expanding stent from a first body lumen, through adjacent luminal walls, to a second body lumen, said apparatus comprising:

a handle having a distal end, a proximal end, and a coupling member at the distal end which can be removably secured to an endoscope;

a catheter operatively coupled to the handle and including a shaft, a self-expanding stent carried on the shaft, and a sheath coaxially received over the shaft and radially constraining the stent on the shaft;

a catheter slide actuator on the handle and coupled to the catheter to advance and retract said catheter as a whole relative to the needle; and

a collar on the handle and coupled to the catheter to advance and retract the sheath over the shaft and stent while the shaft remains stationary relative to the handle in order to release the self-expanding stent.

20. Apparatus as in claim 19, wherein the catheter has a tapered, sharpened, or electrode distal tip to facilitate passage through a penetration in the apposed walls.

21. Apparatus as in claim 19, further comprising a first lock for selectively securing the first slide actuator to the handle.

22. Apparatus as in claim 21, further comprising a second lock for selectively securing the second slide actuator to the handle.

23. Apparatus as in claim 19, wherein the shaft has an axial passage extending therethrough.

24. Apparatus as in claim 23, wherein the axial passage of the shaft is adapted to receive a guidewire.

25. Apparatus as in claim 23, wherein the catheter further comprises a needle slidably disposed in the axial passage of the shaft, said needle being operatively connected to a needle slider on the handle.

26. Apparatus as in claim 25, further comprising a tension wire slidably disposed in an axial passage in the needle, said tension wire having an anchor at its distal end which engages a wall of the second body lumen to provide tension as the catheter shaft and sheath are advanced over the needle.

27. Apparatus as in claim 26, wherein the anchor comprises a self-expanding structure formed integrally with the tension wire.

28. Apparatus as in claim 27, wherein the self-expanding structure comprises a plurality of loops which deploy rearwardly to form a concave structure over the wall of the second body lumen, wherein the concave structure provides clearance for advancing the catheter shaft and sheath.

29. A catheter for delivering a self-expanding stent through adjacent luminal walls, said catheter comprising:

a shaft having a distal end, a proximal end, and an axial passage therethrough;

a needle slidably positioned in the axial passage of the shaft and having a tissue-penetrating distal tip that can be advanced distally beyond the distal end of the shaft and retracted proximally within the passage, said needle having an axial passage therethrough;

a tension wire slidably positioned in the axial passage of the needle and having a deployable anchor at its distal end, wherein said anchor can be distally advanced beyond the distal tip of the needle and proximally retracted into the axial passage of the needle;

a self-expanding stent carried coaxially over the shaft;

a retractable sheath disposed coaxially over the shaft and the stent so that the sheath maintains the stent in a radially constrained configuration and can be retracted to release the stent from constraint and allow the stent to deploy.

30. A catheter as in claim 29, further comprising a handle having a body with a coupling member that can be removably secured to an endoscope to position the catheter shaft within a working channel of the endoscope.

31. A catheter as in claim 30, wherein the handle includes a catheter slide actuator to selectively advance and retract the catheter shaft within the working channel of the endoscope.

32. A catheter as in claim 31, wherein the handle includes a collar actuator to selectively advance and retract the sheath over the shaft to release the self-expanding stent from constraint.

33. A catheter as in claim 32, wherein the handle includes a needle slide actuator to selectively advance and retract the needle relative to the shaft.

34. A catheter as in claim 29, wherein the self-expanding stent has a constrained tubular configuration and an unconstrained configuration with distal and proximal flanges for engaging the luminal walls.

35. A catheter as in claim 29, further comprising a port disposed on a proximal end of the needle to provide for aspiration and/or perfusion through the axial passage of the needle.

36. A catheter as in claim 29, wherein the anchor comprises a self-expanding structure formed integrally with the tension wire.

37. A catheter as in claim 36, wherein the self-expanding structure comprises a plurality of loops which deploy rearwardly to form a concave structure over the wall of the second body lumen, wherein the concave structure provides clearance for advancing the shaft and sheath.