Method and apparatus for delivering combined electrical and drug therapies

• US 20060041276A1
• Filed: 08/20/2004
• Published: 02/23/2006
• Est. Priority Date: 08/20/2004
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Chan, Gregory Waimong
• Granted Patent: US 7,567,841 B2
• Time in Patent Office: Days
• US Class Current: 607/3
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/08 Other bio-electrical signals
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/39622 Pacing therapy
• CPC Class Codes: A61N 1/3968 Constructional arrangements, e.g. casings A61N1/375 takes precedence
• CPC Class Codes: Y10T 29/49002 Electrical device making

Abstract

A cardiac rhythm management (CRM) system includes an implantable medical device that delivers combined electrical and drug therapies. The implantable medical device includes a drug reservoir that is refillable after implantation. In one embodiment, the implantable medical device includes an implantable housing encapsulating a pulse generator circuit and a drug delivery device. In another embodiment, the implantable medical device includes an implantable pulse generator and an implantable drug delivery device fastened to each other.

Claims

1. A cardiac rhythm management (CRM) system, comprising:

an implantable medical device including;

a pulse output circuit to deliver electrical pulses;

a drug delivery device including;

a drug reservoir to contain a drug; and

a reservoir filling port connected to the drug reservoir;

an implant controller, coupled to the pulse output circuit and the drug delivery device, to control delivery of the electrical pulses and the drug; and

an implantable housing to contain the pulse output circuit, the drug delivery device, and the implant controller,

wherein the reservoir filling port is constructed on the implantable housing and includes a self-resealable portion adapted to allow filling of the drug reservoir using a hollow needle.

2. The system of claim 1, wherein the pulse output circuit comprises a pacing circuit to deliver pacing pulses.

3. The system of claim 1, wherein the pulse output circuit comprises a cardioversion/defibrillation circuit to deliver cardioversion/defibrillation shocks.

4. The system of claim 1, wherein the drug delivery device further comprises a drug level monitoring circuit, coupled to the drug reservoir, to monitor a level of the drug in the drug reservoir.

5. The system of claim 4, wherein the drug delivery device further comprises a drug pump to deliver the drug from the drug reservoir, and further comprising at least one implantable lead including:

a proximal end and a distal end, the proximal end connected to the drug delivery device;

one or more drug delivery ports; and

a lumen extending within the implantable lead from the proximal end to the one or more drug delivery ports to allow passage of the drug from the drug delivery device to the one or more drug delivery ports.

6. The system of claim 5, wherein the one or more drug delivery ports comprises at least one drug delivery port at or near the distal end of the at least one implantable lead.

7. The system of claim 5, wherein the one or more drug delivery ports comprises a plurality of drug delivery ports distributed along the at least one implantable lead.

8. The system of claim 5, wherein the lumen is configured to accommodate a portion of a guidewire for implanting the at least one implantable lead.

9. The system of claim 5, wherein the distal end of the implantable lead is configured for endocardial placement.

10. The system of claim 5, wherein the distal end of the implantable lead is configured for epicardial placement.

11. The system of claim 5, wherein the at least one implantable lead further comprises one or more electrodes to which the electrical pulses are delivered from the pulse output circuit.

12. The system of claim 5, further comprising at least a further implantable lead including one or more electrodes to which the electrical pulses are delivered from the pulse output circuit.

13. The system of claim 1, wherein the implantable medical device further comprises a sensor circuit, coupled to the implant controller, to sense one or more signals indicative of a need to deliver at least one or more of the electrical pulses and the drug, and wherein the implant controller comprises a sensor processing circuit coupled to the sensor circuit and a therapy controller coupled to the sensor processing circuit, the therapy controller adapted to control the delivery of the electrical pulses and the drug based on at least the one or more signals.

14. The system of claim 13, wherein the therapy controller comprises a pacing algorithm execution circuit including one or more of a cardiac resynchronization therapy (CRT) algorithm execution circuit and a remodeling control therapy (RCT) algorithm execution circuit.

15. The system of claim 13, wherein the implant controller comprises a command receiver to receive an external command, and the therapy controller is adapted to control the delivery of the electrical pulses and the drug based on at least the one or more signals and the external command.

16. The system of claim 15, further comprising an external system communicating with the implantable medical device, the external system including a user interface including a user input device to receive the external command.

17. A cardiac rhythm management (CRM) system, comprising:

an implantable pulse generator to deliver electrical pulses, the implantable pulse generator including;

a pulse generator circuit; and

a first implantable housing configured to encapsulate the pulse generator circuit; and

an implantable drug delivery device to deliver a drug, the implantable drug delivery device including;

a drug reservoir to contain the drug;

a second implantable housing configured to encapsulate portions of a structure of the implantable drug delivery device including the drug reservoir, the second implantable housing fastened to the first implantable housing; and

a reservoir filling port constructed on the second implantable housing, the reservoir filling port including a self-resealable portion adapted to allow filling of the drug reservoir through a hollow needle.

18. The system of claim 17, wherein the implantable pulse generator comprises one of a pacemaker, a cardiac resynchronization therapy (CRT) device, a remodeling control therapy (RCT) device, a cardioverter/defibrillator, and a pacemaker-cardioverter/defibrillator.

19. The system of claim 17, wherein the implantable drug delivery device further comprises:

a drug level monitoring circuit, coupled to the drug reservoir, to monitor a level of the drug in the drug reservoir; and

a drug pump to delivery the drug from the drug reservoir.

20. The system of claim 19, wherein the implantable drug delivery device further comprises:

a sensor circuit to sense one or more signals indicative of a need to deliver the drug; and

a drug delivery controller to control the delivery of the drug, the drug delivery controller including a sensor processing circuit coupled to the sensor circuit and a therapy controller coupled to the sensor processing circuit, the therapy controller adapted to control the delivery of the drug based on at least the one or more signals.

21. The system of claim 20, wherein the drug delivery controller further comprises a command receiver to receive an external command controlling the delivery of the drug.

22. The system of claim 21, further comprising an external system communicating with the implantable medical device, the external system including a user interface including a user input device to receive the external command.

23. The system of claim 17, wherein the second implantable housing is glued to the first implantable housing using a biocompatible adhesive.

24. The system of claim 17, wherein the second implantable housing is welded to the first implantable housing.

25. The system of claim 17, wherein the second implantable housing is braced to the first implantable housing.

26. The system of claim 17, wherein the second implantable housing is soldered to the first implantable housing.

27. The system of claim 17, wherein the first implantable housing and the second implantable housing have approximately identical major contours.

28. A medical device assembly, comprising:

an implantable drug delivery device including;

a drug reservoir to contain the drug;

an implantable housing adapted to contain portions of a structure of the implantable drug delivery device including the drug reservoir, the implantable housing configured to be attached to an implantable cardiac rhythm management (CRM) device; and

a reservoir filling port constructed on the implantable housing, the reservoir filling port including a self-resealable portion adapted to allow filling of the drug reservoir using a hollow needle; and

means for fastening the implantable drug delivering device to the implantable CRM device.

29. The medical device assembly of claim 28, wherein the implantable drug delivery device further comprises:

a drug level monitoring circuit, coupled to the drug reservoir, to monitor a level of the drug in the drug reservoir; and

a drug pump to delivery the drug from the reservoir.

30. The medical device assembly of claim 29, further comprising at least one implantable lead including:

a proximal end and a distal end, the proximal end configured to be connected to the drug delivery device;

one or more drug delivery ports; and

a lumen extending within the implantable lead from the proximal end to the one or more drug delivery ports to allow passage of the drug from the drug delivery device to the one or more drug delivery ports.

31. The medical device assembly of claim 28, wherein the means for fastening the implantable drug delivering device to the implantable CRM device comprises a biocompatible adhesive.

32. A method for making an implantable cardiac rhythm management (CRM) system, comprising:

providing a pulse generator circuit adapted to deliver electrical pulses to one or more electrodes;

providing a drug delivery device including a drug reservoir;

encapsulating the pulse generator circuit and the drug delivery device using an implantable housing; and

incorporating a self-resealable reservoir filling port onto the implantable housing to allow filling of the drug reservoir using a hollow needle.

33. The method of claim 32, wherein providing the pulse generator circuit comprises providing one or more of a pacemaker circuit, a circuit delivering a cardiac resynchronization therapy (CRT), a circuit delivering a remodeling control therapy (RCT), and a cardioverter/defibrillator circuit.

34. The method of claim 33, further comprising providing a control circuit to control the pulse generator and the drug delivery device.

35. The method of claim 34, further comprising providing a sensor circuit to sense one or more signals each indicative of a cardiac function.

36. The method of claim 35, wherein providing a control circuit comprises providing a feedback control circuit to control a drug delivery based on the one or more signals.

37. The method of claim 32, further comprising providing at least one implantable lead including the one or more electrodes to which the electrical pulses are delivered.

38. The method of claim 37, wherein providing the at least one implantable lead comprises providing a lumen for passing the drug from the drug delivery device to one or more drug delivery ports incorporated into the at least one implantable lead.

39. The method of claim 38, further comprising providing at least one further implantable lead including a lumen for passing the drug from the drug delivery device to one or more drug delivery ports incorporated into the at least one further implantable lead.

40. A method for making an implantable medical device, comprising:

providing an implantable pulse generator including an implantable pulse generator housing;

providing an implantable drug delivery device including a drug reservoir, an implantable drug delivery device housing, and a self-resealable reservoir filling port constructed on the implantable drug delivery device housing to allow filling of the drug reservoir using a hollow needle; and

fastening the implantable drug delivery device housing to the implantable pulse generator housing.

41. The method of claim 40, wherein providing the implantable pulse generator comprises providing one of an implantable pacemaker, an implantable cardiac resynchronization therapy (CRT) device, a implantable remodeling control therapy (RCT) device, an implantable cardioverter/defibrillator, and an implantable pacemaker-cardioverter/defibrillator.

42. The method of claim 41, further comprising providing implantable device housings having approximately identical major contours for use as the implantable pulse generator housing and the implantable drug delivery device housing.

43. The method of claim 41, wherein fastening the implantable drug delivery device housing to the implantable pulse generator housing comprises gluing the implantable drug delivery device housing to the implantable pulse generator housing using a biocompatible adhesive.

44. The method of claim 41, wherein fastening the implantable drug delivery device housing to the implantable pulse generator housing comprises welding the implantable drug delivery device housing to the implantable pulse generator housing.

45. The method of claim 41, wherein fastening the implantable drug delivery device housing to the implantable pulse generator housing comprises bracing the implantable drug delivery device housing to the implantable pulse generator housing.

46. The method of claim 41, wherein fastening the implantable drug delivery device housing to the implantable pulse generator housing comprises soldering the implantable drug delivery device housing to the implantable pulse generator housing.