Method and apparatus for introducing endolymphatic instrumentation

• US 8,126,538 B2
• Filed: 06/06/2006
• Issued: 02/28/2012
• Est. Priority Date: 06/06/2006
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Shuros, Allan C., Westlund, Randy, Brooke, M. Jason
• Primary Examiner(s): Chen, Tse
• Assistant Examiner(s): Luong, Peter
• Application Number:
  US11/422,423
• Publication Number:
  US 20080009719A1
• Time in Patent Office: 2,093 Days
• Field of Search: 607/17, 607/18, 600/427
• US Class Current: 600/427
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/358 Detecting ST segments
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: A61B 5/418 lymph vessels, ducts or nodes
• CPC Class Codes: A61M 2202/0405 Lymph
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes

Abstract

Described herein are a method and apparatus for introducing instrumentation into the lymphatic system that can be used for physiological monitoring and/or delivery of therapy. Such instrumentation, for example, may include one or more sensors for measuring physiological variables and/or one or more instruments for delivering therapy that is adapted to be disposed within a lymphatic vessel.

Claims

1. A method, comprising:

introducing a catheter having a lymphatic instrument incorporated therein into a patient'"'"'s venous system;

advancing the catheter through the venous system to reach the thoracic duct;

advancing the catheter through the thoracic duct into a lymphatic vessel;

fluoroscopically imaging the patient'"'"'s lymphatic vessel as the lymphatic instrument is guided therethrough;

opening lymphatic valves by drawing a vacuum through a lumen of the catheter in order to create a negative pressure gradient within the lymphatic vessel;

simultaneously pushing the catheter through the lymphatic valves as they are opened by the negative pressure gradient; and

positioning the lymphatic instrument at a selected location within the patient'"'"'s lymphatic vessel to deliver therapy or sense one or more physiological variables.

2. The method of claim 1 further comprising introducing the lymphatic instrument by means of a guide wire.

3. The method of claim 1 further comprising implanting an implantable control device that communicates with the lymphatic instrument.

4. The method of claim 3 wherein the lymphatic instrument is incorporated into a lead adapted for connecting to the implantable control device.

5. The method of claim 1 wherein the lymphatic instrument is incorporated into a satellite unit that wirelessly communicates with an implantable or external control device.

6. The method of claim 5 further comprising implanting a stent incorporating the satellite unit with the catheter.

7. The method of claim 1 further comprising navigating the lymphatic instrument to the target location by delivering an electrical stimulus to nerves and sensing nerve activity.

8. The method of claim 1 further comprising employing an electro-stimulator incorporated into the catheter to open lymphatic valves in order to facilitate the passage of the catheter therethrough.

9. The method of claim 1 further comprising employing an inflatable balloon incorporated into the catheter to open lymphatic valves in order to facilitate the passage of the catheter therethrough.

10. The method of claim 1 further comprising employing one or more guide magnets and a catheter or guide wire with a ferromagnetic tip to guide the lymphatic instrument through the lymphatic system.

11. The method of claim 1 further comprising overlapping a fluoroscopic image with an anatomical image of the patient'"'"'s body to facilitate placement of the lymphatic instrument at a selected location.

12. The method of claim 1 further comprising cannulating the lymphatic ostium of the patient'"'"'s thoracic duct, and guiding the lymphatic instrument through the thoracic duct to a selected target location.

13. The method of claim 12 further comprising assisting initial cannulation of the lymphatic ostium by use of an endovascular grasping instrument for manipulating the lymphatic ostium.

14. The method of claim 13 further comprising introducing the endovascular grasping instrument through the femoral or mammary vein of the patient.

15. A system for introducing endolymphatic instrumentation, comprising:

a stent incorporating a lymphatic instrument configured to measure a physiological variable and that is configured to communicate wirelessly with an external or implantable device;

a catheter configured to implant the stent;

a catheter controller configured to mechanically push the catheter into the lymphatic system of a patient;

a vacuum actuator configured to draw a vacuum through a lumen of the catheter in order to create a pressure gradient within a lymphatic vessel and open lymphatic valves as the catheter is pushed therethrough by the catheter controller;

wherein the system is configured to operate the catheter controller to simultaneously push the catheter as vacuum is drawn through the lumen of the catheter; and

,

a workstation that provides a user interface configured to control operation of the system and which provides an output configured to actuate the catheter controller and vacuum actuator.

16. The system of claim 15 further comprising an electro-stimulator for providing electrical energy to an electrode of the catheter in order to cause contraction of smooth muscle in the walls of the lymphatic vessel and create a pressure gradient to open lymphatic valves.

17. The system of claim 15 further comprising:

a ferromagnetic tip of the catheter;

movable guiding magnets for magnetically guiding the tip of the catheter; and

,

a magnet actuator interfaced to the workstation actuating the guiding magnets.

18. The system of claim 15 further comprising a fluoroscope is interfaced to the workstation configured to produce a fluoroscopic image of the patient.

19. The system of claim 18 further comprising an image repository interfaced to the workstation that stores anatomical images of the patient obtained with one or more other imaging modalities such as conventional x-ray, CAT, MRI, and ultrasound and which allows an operator to overlap an anatomical image from the image repository with the fluoroscopic image in order to provide anatomical landmarks for guiding the catheter to a selected location.