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

• US 20060047318A1
• Filed: 08/25/2004
• Published: 03/02/2006
• Est. Priority Date: 08/25/2004
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Pastore, Joseph M., Ross, Jeffrey
• Granted Patent: US 7,621,906 B2
• Time in Patent Office: Days
• US Class Current: 607/3
• 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 at least a portion made of an electrically sensitive polymer having a structure that is electrically controllable by applying an electric field on the electrically sensitive polymer;

a drug stored in the drug storage device; and

one or more electrodes, coupled to the drug storage device, to apply the electric field on the electrically sensitive polymer; and

an implantable lead coupled to the drug delivery device, the implantable lead including a proximal end, a distal end, a lead connector at the proximal end, and one or more conductors extending from the proximal end to the distal end, the one or more conductors each connected to one electrode of the one or more electrodes at the distal end.

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

5. The system of claim 1, wherein the electrically sensitive polymer has an 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 drug storage device comprises a polymeric matrix made of the electrically sensitive polymer, and wherein a drug is embedded in the polymeric matrix.

9. The system of claim 1, wherein the drug storage device comprises a storage compartment including a chamber and a wall forming the chamber, at least a portion of the wall made of the electrically sensitive polymer, and wherein the drug is stored in the chamber.

10. The system of claim 1, wherein the one or more electrodes comprise a plurality of electrodes each controlled to apply an electrical field of an individually programmed amplitude on a portion of the electrically sensitive polymer.

11. The system of claim 1, wherein the implantable drug delivery device is configured for epicardial attachment.

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

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

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

15. 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.

16. The system of claim 1, further comprising an implantable medical device coupled to the drug delivery device via the implantable lead, the implantable medical device including:

a device connector configured to mate the lead connector; and

a drug delivery controller, coupled to the device connector, to produce one or more drug delivery signals and deliver the one or more drug delivery signals to the one or more electrodes.

17. The system of claim 16, wherein the implantable medical device further includes a command receiver, coupled to the drug delivery controller, to receive an external command transmitted to the implantable medical device, and wherein the drug delivery controller is adapted to produce the one or more drug delivery signals based on the external command.

18. The system of claim 16, wherein the drug delivery controller comprises an amplitude controller to produce the one or more drug delivery signals to control an amplitude of the electric field.

19. The system of claim 16, wherein the drug delivery controller comprises a timer to produce the one or more drug delivery signals to control a timing of the application of the electric field.

20. The system of claim 16, wherein the drug delivery controller comprises a duty-cycle controller to produce the one or more drug delivery signals to control a duty cycle of the electric field.

21. The system of claim 16, 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.

4. The system of claim 4, 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.

22. A system, comprising:

a drug delivery device including a storage compartment having a wall forming a chamber, at least a portion of the wall being made of an electrically sensitive polymer having a structure being electrically controllable by applying an electric field on the electrically sensitive polymer; and

a drug stored in the chamber.

23. The system of claim 22, wherein the electrically sensitive polymer has an electrically controllable porosity.

24. The system of claim 22, wherein the electrically sensitive polymer has an electrically controllable binding affinity.

25. The system of claim 22, wherein the drug delivery device further comprises:

a controller coupled to the electrically sensitive polymer; and

a power source coupled to the controller.

26. The system of claim 25, wherein the drug delivery device further comprises a telemetry circuit to receive a drug delivery command.

27. The system of claim 26, wherein the drug delivery device further comprises a sensor to sense a physiological signal, and wherein the controller comprises a drug delivery signal generator to produce a drug delivery signal based on the sensed physiological signal.

28. The system of claim 26, wherein the drug delivery device is an implantable drug delivery device.

29. The system of claim 26, wherein the drug delivery device is a drug delivery patch configured for skin attachment.

30. An apparatus for treating a heart, comprising:

an implantable lead including one or more electrodes configured to provide electrical connection to the heart;

an electrically sensitive polymeric material coated on at least a portion of the implantable lead, the electrically sensitive polymeric material having a structure controllable by applying an electrical field thereon; and

a drug embedded in the electrically sensitive polymeric material.

31. The apparatus of claim 30, wherein the at least the portion of the implantable lead has a length of at least approximately 2 millimeters.

32. The apparatus of claim 30, wherein the electrically sensitive polymeric material coated on the at least the portion of the implantable lead has a thickness of approximately 0.01 to 2 millimeters.

33. The apparatus of claim 30, further comprising an implantable medical device coupled to the implantable lead, the implantable medical device includes a drug delivery controller to generate a drug delivery signal.

34. The apparatus of claim 33, wherein the drug delivery controller is connected to the implantable lead and delivers the drug delivery signal to the lead to create the electric field.

35. An article for treating a heart having a myocardium, comprising:

a bulking agent adapted to bulk at least a portion of the myocardium, the bulking agent including an electrically sensitive polymeric material having a structure controllable by applying an electrical field onto the bulking agent; and

a drug embedded in the electrically sensitive polymeric material.

36. The article of claim 35, wherein the drug comprises one or more biological agents.

37. The article of claim 35, 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.

38. A method, comprising:

applying an electric field to an electrically sensitive polymer containing a drug to control the release of the drug, wherein the electrically sensitive polymer has a structure sensitive to the electric field, wherein applying the electric field to the electrically sensitive polymer comprises delivering a plurality of electrical signals each controlling an electric field strength in a portion of the electrically sensitive polymer to control a spatial distribution of electric field strength in the electrically sensitive polymer.

39. The method of claim 38, wherein delivering the plurality of electrical signals comprises controlling an amplitude of each electrical signal of the plurality of electrical signals to control spatial distribution of electric field strength.

40. The method of claim 39, wherein delivering the plurality of electrical signals further comprises controlling a duty cycle of each electrical signal of the plurality of electrical signals.

41. The method of claim 39, wherein delivering the plurality of electrical signals comprises delivering the plurality of electrical signals based on a predetermined schedule.

42. The method of claim 39, wherein delivering the plurality of electrical signals comprises delivering the plurality of electrical signals from an implantable medical device.

43. The method of claim 42, furthering comprising sensing a signal, and wherein delivering the plurality of electrical signals further comprises delivering the plurality of electrical signals based on the sensed signal.

44. A method for treating a heart having a myocardium, comprising:

controlling a release of a drug embedded in a bulking agent made a material including at least an electrically sensitive polymer and implanted in the myocardium by applying an electrical field to the bulking agent, wherein the electrically sensitive polymer has a structure sensitive to the electric field.

45. The method of claim 44, wherein controlling the release of the drug comprises controlling a rate at which the drug is released by controlling an amplitude of the electrical field.

46. The method of claim 44, wherein controlling the release of the drug comprises controlling a timing according to which the drug is released by controlling a duty cycle of the electrical field.

47. The method of claim 44, wherein controlling the release of the drug comprises applying the electric field according to a predetermined schedule.

48. The method of claim 44, wherein applying the electrical field comprises delivering an electrical signal from an implantable medical device.

49. The method of claim 48, further comprising sensing a signal, and wherein delivering the electrical signal comprises producing the electrical signal based on the sensed signal.