Method and apparatus for endolymphatic drug delivery

• US 8,905,999 B2
• Filed: 09/01/2006
• Issued: 12/09/2014
• Est. Priority Date: 09/01/2006
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Shuros, Allan C., Kramer, Andrew P., Baynham, Tamara Colette, Cawthra, James, Brooke, M. Jason
• Primary Examiner(s): Sirmons, Kevn C
• Assistant Examiner(s): GRAY, PHILLIP A
• Application Number:
  US11/469,793
• Publication Number:
  US 20080097412A1
• Time in Patent Office: 3,021 Days
• Field of Search: 6048901-8921, 604/131, 604/151, 604/96.01, 604/164.01, 604/523
• US Class Current: 604/890.1
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2202/0405 Lymph
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems

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 device, comprising:

an implantable housing;

a drug delivery apparatus contained within the implantable housing;

a catheter adapted for disposition within a lymphatic vessel and having a lumen communicating with the drug delivery apparatus;

an occluding structure incorporated into the catheter for blocking flow of lymphatic fluid in the lymphatic vessel;

a vacuum actuator for drawing 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; and

,

control circuitry contained within the implantable housing for controlling operation of the occluding structure and drug delivery apparatus to enable delivery of a drug out of the catheter distally from the occluding structure and into the lymphatic vessel.

2. The device of claim 1 wherein the occluding structure is an inflatable balloon mounted on the catheter and further comprising an inflation apparatus contained within the implantable housing for inflating the balloon through a balloon inflation lumen of the catheter.

3. The device of claim 1 wherein the catheter incorporates a plurality of chambers that may be individually pressurized to effect selective stiffening of different portions of the catheter and facilitate passage of the catheter through a lymphatic vessel.

4. The device of claim 1 further comprising a chemosensor for use in conjunction with selectively permeable concentric layers of the catheter to sense the concentrations of different molecules in the lymphatic fluid.

5. The device of claim 1 wherein the drug delivery apparatus is a mechanical pump connected to a drug reservoir.

6. The device of claim 1 further comprising sensing circuitry for sensing a physiological signal and wherein the control circuitry is configured to deliver the drug in a manner responsive to the physiological signal.

7. The device of claim 6 further comprising an electrode connected to the sensing circuitry by a lead adapted for disposition within the heart and wherein the sensing circuitry is configured to sense cardiac electrical activity.

8. The device of claim 6 further comprising a lymphatic sensor connected to the sensing circuitry for sensing the lymphatic fluid within the lymphatic vessel.

9. The device of claim 1 further comprising a tactilely or magnetically actuated switch operable to initiate or stop delivery of the drug.

10. The device of claim 1 further comprising a telemetry transceiver interfaced to the control circuitry for enabling wireless communication with the device.

11. A method for delivering a drug to a patient, comprising:

implanting an implantable drug delivery device connected to a catheter;

introducing the catheter into a lymphatic vessel of the patient;

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;

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

operating control circuitry within the implantable drug delivery device to deliver a drug through the catheter into the patient'"'"'s lymphatic vessel.

12. The method of claim 11 further comprising:

inflating a balloon mounted on the catheter to block antegrade flow of lymphatic fluid; and

,

delivering the drug out of the catheter distal to the balloon to enable retrograde flow of the drug through the lymphatic vessel.

13. The method of claim 11 further comprising individually pressurizing selected chambers of the catheter to effect selective stiffening of different portions of the catheter and facilitate passage of the catheter through a lymphatic vessel.

14. The method of claim 11 further comprising sensing a physiological signal and delivering the drug in a manner responsive to the physiological signal.

15. The method of claim 14 wherein the physiological signal is sensed by sensing circuitry within the implantable drug delivery device interfaced to the control circuitry.

16. The method of claim 15 further comprising sensing cardiac electrical activity with an electrode disposed within the heart and connected to the sensing circuitry by a lead and controlling the delivery of the drug in accordance therewith.

17. The method of claim 15 further comprising sensing the lymphatic fluid within the lymphatic vessel using a lymphatic sensor connected to the sensing circuitry and controlling the delivery of the drug in accordance therewith.

18. The method of claim 11 further comprising operating a tactilely or magnetically actuated switch operable to control delivery of the drug.

19. The method of claim 11 further comprising communicating with the control circuitry via telemetry to control delivery of the drug.

20. The method of claim 11 wherein the drug is selected from a group that consists of a pain relieving agent, a cancer chemotherapeutic agent, an anti-inflammatory agent, an embolizing agent, a cardiac drug, an antibiotic agent, a gene therapeutic agent, and a biological cellular agent.