Method and apparatus for performing needle guided interventions

• US 8,328,837 B2
• Filed: 12/07/2005
• Issued: 12/11/2012
• Est. Priority Date: 12/08/2004
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Xlumena, Inc. (Boston Scientific Corporation)
• Inventors: Binmoeller, Kenneth
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): MILES, JONATHAN WADE
• Application Number:
  US11/886,499
• Publication Number:
  US 20090030380A1
• Time in Patent Office: 2,561 Days
• Field of Search: 604/64.01, 604/101.04, 604/167.01, 604/167.02, 604/167.03, 604/167.04, 604/167.05, 604/167.06, 604/533, 604/536, 604/164.01, 606/185
• US Class Current: 606/185
• 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 configured to be inserted into a hollow body organ through a working channel of an endoscope having a central axis, the apparatus comprising:

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

the handle member having a connecting member configured to detachably affix the handle member to the proximal end of the endoscope to prevent relative movement therebetween,

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

the needle actuator having a locking mechanism configured to fix the location of the needle actuator relative to the handle member and the endoscope,

a dilation balloon located near the distal end of the catheter device and in fluid communication with the inflation lumen to allow inflation of the balloon,

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

wherein the needle actuator is configured to move relative to the handle member and the endoscope to slidably move the needle in the through lumen of the catheter device,

wherein the catheter device actuator is configured to move relative to the handle member, the endoscope and the needle to slidably move the catheter device in the working channel of the endoscope,

wherein the needle actuator locking mechanism may be locked to allow the catheter to be advanced or retracted over the needle while the needle and the endoscope remain stationary,

and wherein the needle may be advanced and retracted independently from the catheter.

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

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

8. The apparatus 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 apparatus of claim 1, 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.

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