SYSTEM AND METHOD FOR TRANSLUMINAL ACCESS

• US 20090281379A1
• Filed: 04/21/2009
• Published: 11/12/2009
• Est. Priority Date: 05/12/2008
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Xlumena, Inc. (Boston Scientific Corporation)
• Inventors: Sander, Fiona M., Binmoeller, Kenneth F., Allen, Michael P.
• Application Number:
  US12/427,254
• Publication Number:
  US 20090281379A1
• Time in Patent Office: Days
• US Class Current: 600/106
• 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 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/0034 adapted to be inserted through a working channel of an endoscope
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/1103 Approximator
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/3486 Balloon
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/09125 Device for locking a guide wire in a fixed position with respect to the catheter or the human body
• CPC Class Codes: A61M 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties with different compartments A61M2025/1072
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

A translumenal access system includes a translumenal access catheter, a trocar, and one or more guidewires. The trocar may be introduced through adjacent tissue layers, typically from an endoscope, and the translumenal access catheter introduced through the resulting penetration over the trocar. A balloon on the catheter may be used to dilate the penetration, and an enlarged distal portion of the balloon may be used to draw the tissue layers into apposition. The first stent may be exchanged for the trocar and a second stent may be introduced through a side port on the access catheter. The stents may be then used to introduced catheters or other interventional tools, optionally for delivering one or more stents to the enlarged tissue penetration.

Claims

1. A method for positioning two guidewires between a first body lumen and a second body lumen, said method comprising:

advancing a tissue penetrating tool from the first body lumen into the second body lumen to form a passage through the luminal walls;

advancing a balloon catheter over the trocar to position a dilation balloon within the passage;

inflating the balloon to dilate the passage;

exchanging a first guidewire for the tool;

advancing the catheter further into the second body lumen so that a side wire port on the catheter proximal of the balloon is within the second body lumen;

advancing a second guidewire through the side port into the second body lumen; and

withdrawing the balloon catheter to leave the first and second guidewires in place through the dilated passage.

2. A method as in claim 1, further comprising advancing a first stent placement catheter over the first guidewire and placing a first stent in the dilated passage.

3. 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 or structure is selected from the group consisting of a bile duct, a gallbladder, a pancreas, a pancreatic duct, a pancreatic pseudocyst, a urinary bladder, and a liver.

4. A method as in claim 2, further comprising advancing a second stent placement catheter over the second guidewire and placing a second stent in the dilated passage adjacent to the first stent.

5. A method as in claim 3, wherein the first body lumen is a stomach and the second body lumen is a pseudocyst.

6. A method for dilating a tissue passage between a first body lumen and a second body lumen or structure, said method comprising:

advancing a tissue penetrating tool from the first body lumen into the second body lumen to form a passage through the luminal walls;

advancing a balloon catheter over the tool to position a distal portion of a dilation balloon beyond the passage to within the second body lumen or structure;

inflating said distal portion of the balloon beyond the passage while a proximal portion of the balloon remains uninflated;

tensioning the balloon catheter proximally so that said inflated distal portion of the balloon engages the wall of the second body lumen and draws the second wall against the first wall to place said walls in apposition; and

inflating the proximal portion of the balloon to dilate the passage through the tissue layers.

7. A method as in claim 6, 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 or structure is selected from the group consisting of a bile duct, a gallbladder, a pancreas, a pancreatic duct, a pancreatic pseudocyst, a urinary bladder, and a liver.

8. A method as in claim 6, further comprising exchanging the trocar for a guidewire.

9. A method as in claim 8, further comprising advancing a stent placement catheter over the guidewire and placing a stent in the dilated passage.

10. A translumenal access system comprising:

a first guidewire;

a second guidewire;

a tissue penetrating tool; and

a translumenal access catheter including;

(a) a catheter body having a proximal end, a distal end, a central lumen and a side lumen; and

(b) a dilation balloon on the catheter body near the distal end;

wherein the central lumen extends from the proximal to the distal end of the catheter body and exchangeably receives the tool and the first guidewire and wherein the side lumen extends from the proximal end of the catheter body to a location immediately proximal of the dilation balloon and removably receives the second guidewire.

11. A system as in claim 10, wherein the catheter further includes

(c) a handle assembly attachable to the proximal end of the catheter body, wherein the handle is configured to lock to an endoscope when the catheter body is within a working channel of the endoscope.

12. A system as in claim 11, wherein the handle comprises an inner core which couples to the catheter body and an outer grip which couples to the tool, wherein a user can advance and retract the grip relative to the inner core to advance and retract the tool relative to the catheter body.

13. A system as in claim 12, further comprising a catheter body adjustment mechanism movably positioned in the inner core to axially advance and retract the catheter body relative to the inner core, outer grip, and the tool.

14. A system as in claim 13, further comprising a tool depth adjustment mechanism on the catheter body to limit the distal motion of the outer grip and the tool puncture depth.

15. A system as in claim 13, further comprising a tool looking mechanism on the outer grip to holder the outer grip and tool in a fixed position relative to the inner core.

16. A catheter and penetrating tool assembly comprising:

a catheter body having a proximal end, and distal end, and a central lumen;

a tissue penetrating tool slidably disposed in the central lumen, said tool having a tissue-penetrating distal end; and

a handle attachable to the proximal end of the catheter body, said handle including an inner core with a catheter advancement mechanism which couples to the catheter body and an outer grip which couples to the tool, wherein a user can advance and retract the grip relative to the inner core to advance and retract the tool relative to the catheter body.

17. An assembly as in claim 16, further comprising a catheter body adjust mechanism on the inner core to axially advance and retract the catheter body relative to the handle and the tool.

18. An assembly as in claim 17, further comprising a tool adjustment mechanism on the outer grip to axially advance and retract the tool relative to the handle and the catheter body.

19. An assembly as in claim 16, wherein the tissue penetrating tool comprises a trocar.

20. An assembly as in claim 16, wherein the tissue penetrating tool has an electrosurgical tip which permits radiofrequency current assisted tissue penetration.