Method and Apparatus for Performing Needle Guided Interventions

• US 20090030380A1
• Filed: 12/07/2005
• Published: 01/29/2009
• Est. Priority Date: 12/08/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Xlumena, Inc. (Boston Scientific Corporation)
• Inventors: Binmoeller, Kenneth
• Granted Patent: US 8,328,837 B2
• Time in Patent Office: Days
• US Class Current: 604/264
• CPC Class Codes: A61B 1/00133 Drive units for endoscopic tools inserted through or with the endoscope
• CPC Class Codes: A61B 1/018 for receiving instruments
• 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 2017/00278 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 2017/00367 Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An apparatus and method for performing needle guided interventions and especially needle guided dilations of tissue to create a therapeutic conduit between two luminal organs or structures. The device is particularly useful for creation of an artificial lumen between two hollow body organs using the working lumen of an endoscope.

Claims

1. An apparatus which is inserted into a hollow body organ through a working channel of an endoscope having a central axis comprising:

a handle which houses a catheter device actuator and a needle actuator,

the handle capable of detachably connecting to the proximal end of the endoscope,

the catheter device actuator coupled to the proximal end of an elongated catheter device having a proximal end, a distal end, and a through lumen,

and an elongated needle positioned in the through lumen of the catheter device with the needle actuator coupled to the proximal end of the needle.

2. The catheter device actuator of claim 1, wherein the catheter device actuator is capable of translating the position of the catheter device along the central axis of the endoscope;

3. The catheter device actuator of claim 2, wherein the actuator moves the catheter device between 2 cm and 10 cm relative to the endoscope.

4. The catheter device actuator of claim 2, wherein the catheter device actuator can move the catheter device independently of the needle along the central axis of the endoscope.

5. The catheter device actuator of claim 4, wherein the catheter device actuator has a locking member to fix the position of the catheter device relative to the endoscope.

6. The needle actuator of claim 1, wherein the needle actuator is capable of translating the position of the needle along the central axis of the endoscope.

7. The needle actuator of claim 6, wherein the actuator moves the needle between 2 cm and 10 cm relative to the endoscope.

8. The needle actuator of claim 6, wherein the needle actuator can move the needle independently of the catheter device along the central axis of the endoscope.

9. The needle actuator of claim 8, wherein the needle actuator has a locking member to fix the position of the needle relative to the endoscope.

10. The catheter device of claim 1, wherein the catheter device includes a balloon coupled to the distal portion of the catheter device.

11. The catheter device of claim 10, wherein the catheter device includes an inflation lumen and an inflation port to inflate and deflate the balloon.

12. The catheter device of claim 11, wherein the catheter device has at least one radiopaque marker band positioned near the balloon;

such marker band visible when viewed with a fluoroscope or x-ray.

13. The needle of claim 1, wherein the needle is hollow and a removable elongated stylet is positioned inside the through lumen of the needle.

14. An apparatus which is inserted into a hollow body organ through a working channel of an endoscope comprising:

a catheter device and a needle, the proximal portion of the catheter device and needle are coupled to a handle, the catheter device and the needle can move back and forth inside the working channel of the endoscope and the position of the catheter device or needle relative to the endoscope can be fixed.

15. An apparatus which is inserted into a hollow body organ through a working channel of an endoscope comprising:

a catheter device and a needle that are capable of independently moving inside the working channel of the endoscope, the proximal portions of the catheter device and needle are coupled to a handle, the handle having at least one locking member to lock the handle to the endoscope, the catheter device having at least one locking member to lock the handle to the endoscope,

and the needle having at least one locking member to lock the needle to the endoscope.

16. A system to form a tissue passageway in the wall of a hollow body organ comprising:

an endoscope, a handle detachably coupled to the endoscope, an elongated catheter device positioned inside a working lumen of the endoscope,

an elongated needle positioned inside a working lumen of the catheter device,

the proximal end of the catheter device moveably coupled to the handle,

the proximal end of the needle moveably coupled to the handle,

and the handle having actuators to controllably move the catheter device or the needle along the axis of the endoscope.

17. A method of forming a passageway in the wall of a hollow body organ comprising:

placing an apparatus into the working channel of an endoscope and coupling the apparatus to the proximal end of an endoscope,

positioning the distal end of the endoscope near the wall of a hollow body organ,

advancing a needle across the organ wall with a needle actuator to form a passageway and fixing the needle to the endoscope using a locking member,

advancing a catheter device having a distal dilation balloon over the needle and through the passageway using a catheter device actuator and fixing the catheter device to the endoscope using a locking member,

and inflating the balloon to enlarge the passageway.

18. The method of claim 17 further comprising:

removing the needle from inside the catheter device and placing one or more guidewires through the catheter device and into the passageway,

and deflating the balloon and withdrawing the apparatus leaving the guidewire to maintain access to the passageway.

19. The method of claim 17, whereby the passageway forms a conduit between the hollow body organ and a duct.

20. The duct of claim 19, where the duct is a pancreatic duct or bile duct.