Method and apparatus to deliver drug and pacing therapy for treatment of cardiac disorders

• US 7,621,906 B2
• Filed: 08/25/2004
• Issued: 11/24/2009
• Est. Priority Date: 08/25/2004
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Pastore, Joseph M., Ross, Jeffrey
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Mehta; Bhisma
• Application Number:
  US10/925,508
• Publication Number:
  US 20060047318A1
• Time in Patent Office: 1,917 Days
• Field of Search: 604/890.1, 604/891.1, 604/19, 604/20, 604/21, 607/120
• US Class Current: 604/891.1
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428
• CPC Class Codes: A61N 1/3962 in combination with another heart therapy
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

A drug delivery system uses an electrically sensitive polymer to store a drug and applies an electric field onto the electrically sensitive polymer for quantitatively and temporally controlled drug delivery. In one embodiment, the drug delivery system is part of a cardiac rhythm management (CRM) system that includes an implantable CRM device and an implantable drug delivery device. The implantable CRM device delivers electrical therapies to a heart and controls the implantable drug delivery device by producing the electrical field with controllable amplitude, frequency, and timing.

Claims

1. A system, comprising:

an implantable drug delivery device including;

a drug storage device including a polymeric matrix made of an electrically sensitive polymer having a structure that is electrically controllable by applying an electric field on the electrically sensitive polymer, the structure including an electrically controllable porosity or an electrically controllable binding affinity;

a drug embedded in the polymeric matrix; and

a plurality of electrodes, coupled to the drug storage device, the plurality of electrodes to apply a plurality of electric fields each on a portion of the electrically sensitive polymer and having an individually controllable amplitude; and

an implantable lead including a proximal end including a lead connector providing for a detachable connection to an implantable cardiac rhythm management (CRM) device and a distal end at the implantable drug delivery device, the implantable lead providing for electrical connections between the implantable CRM device and the plurality of electrodes to allow a plurality of drug delivery signals controlling the application of the plurality of electric fields to be delivered from the implantable CRM device to the plurality of electrodes.

2. The system of claim 1, wherein the electrically sensitive polymer has the electrically controllable porosity.

3. The system of claim 2, wherein the electrically sensitive polymer is configured to enter a substantially porous state upon application of the electrical field at a first amplitude and a substantially non-porous state upon application of the electrical field at a second amplitude.

4. The system of claim 2, wherein the electrically sensitive polymer is configured to enter a substantially porous state upon application of the electrical field and a substantially non-porous state upon removal of the electrical field.

5. The system of claim 1, wherein the electrically sensitive polymer has the electrically controllable binding affinity.

6. The system of claim 5, wherein the electrically sensitive polymer is configured to enter a state of low binding affinity upon application of the electrical field at a first amplitude and a state of high binding affinity upon application of the electrical field at a second amplitude.

7. The system of claim 5, wherein the electrically sensitive polymer is configured to enter a state of low binding affinity upon application of the electrical field and a state of high binding affinity upon removal of the electrical field.

8. The system of claim 1, wherein the implantable drug delivery device comprises a patch configured for epicardial attachment.

9. The system of claim 1, wherein the implantable drug delivery device is configured for intracardiac placement.

10. The system of claim 1, wherein the implantable drug delivery device is configured for intravascular placement.

11. The system of claim 1, wherein the drug comprises at least one biological agent.

12. The system of claim 1, wherein the drug comprises one or more of:

an agent treating arrhythmia;

an agent treating heart failure;

an agent treating diastolic dysfunction;

an agent providing ischemia protection;

an agent altering fibrosis;

an angiogenic agent;

a cytokine;

an agent recruiting cells for a cell therapy; and

an agent promoting cellular regeneration.

13. The system of claim 1, comprising the implantable CRM device, and wherein the implantable CRM device includes a drug delivery controller to produce the plurality of drug delivery signals and deliver the plurality of drug delivery signals to the plurality of electrodes.

14. The system of claim 13, wherein the implantable CRM device includes an implant controller, coupled to the drug delivery controller, to receive an external command transmitted to the implantable CRM device, and wherein the drug delivery controller is adapted to produce the plurality of drug delivery signals based on the external command.

15. The system of claim 14, further comprising:

an external device communicatively coupled to the implantable CRM device via telemetry;

a remote device including a user input configured to allow a user to enter the external command; and

a network configured to provide bi-directional communication between the external device and the remote device.

16. The system of claim 13, wherein the drug delivery controller is adapted to produce the plurality of drug delivery signals to control an amplitude of each electric field of the plurality of electric fields.

17. The system of claim 13, wherein the drug delivery controller is adapted to produce the plurality of drug delivery signals to control a timing of the application of each electric field of the plurality of electric fields.

18. The system of claim 13, wherein the drug delivery controller is adapted to produce the plurality of drug delivery signals to control a duty cycle of each electric field of the plurality of electric fields.

19. The system of claim 13, further comprising a sensor to sense a signal indicative of an effect of drug delivery, and wherein the drug delivery controller is adapted to produce the one or more drug delivery signals by using the signal indicative of the effect of drug delivery as a feedback control signal.