Method and apparatus for delivering combined electrical and drug therapies

• US 7,567,841 B2
• Filed: 08/20/2004
• Issued: 07/28/2009
• Est. Priority Date: 08/20/2004
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Chan, Gregory Waimong
• Primary Examiner(s): Bockelman; Mark W
• Assistant Examiner(s): Bertram; Eric D
• Application Number:
  US10/922,650
• Publication Number:
  US 20060041276A1
• Time in Patent Office: 1,803 Days
• Field of Search: 607/3, 607/30
• US Class Current: 607/30
• 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 adapted to start releasing a drug in response to a drug delivery signal, the drug delivery device including;

a drug reservoir containing a drug for treating heart failure; and

a reservoir filling port connected to the drug reservoir;

a sensor circuit to sense one or more signals indicative of a need for and an effect of the delivery of the electrical pulses and the drug;

an implant controller, coupled to the pulse output circuit, the drug delivery device, and the sensor circuit, the implant controller including a sensor processing circuit adapted to process the one or more signals and a therapy controller adapted to control delivery of the electrical pulses and the drug using the processed one or more signals, the therapy controller adapted to produce the drug delivery signal in response to at least an external command and execute a pacing algorithm adapted to enhance one or more effects of the drug, the therapy controller adapted to control delivery of pacing pulses by alternately executing a cardiac resynchronization therapy (CRT) algorithm adapted to maximize a measure of hemodynamic performance and a remodeling control therapy (RCT) algorithm adapted to alter a cardiac remodeling process; 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; and

an external system including an external device, a network, and a remote device, the external device communicatively coupled to the implantable medical device via telemetry, the network providing for communication between the external device and the remote device, the remote device including a user input device adapted to receive the external command.

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 comprise at least one drug delivery port at or near the distal end of the at least one implantable lead.

7. The system of claim 6, wherein the at least one drug delivery port at or near the distal end comprises a porous polymer for controlling a speed of drug release.

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

9. 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.

10. The system of claim 5, wherein the at least one implantable lead comprises an endocardial lead with the distal end configured for endocardial placement, the endocardial lead including one or more electrodes to which the electrical pulses are delivered from the pulse output circuit.

11. The system of claim 5, wherein the distal end of the implantable lead is configured for epicardial placement and including one or more electrodes to which the electrical pulses are delivered from the pulse output circuit.

12. 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.

13. 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.

14. The system of claim 1, wherein the implant controller comprises a command receiver to receive the 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.

15. The system of claim 1, wherein the drug reservoir is configured to contain a plurality of drugs, and the implant controller is adapted to control the delivery of each drug of the plurality of drugs individually by producing a drug delivery signal specific to the each drug of the plurality of drugs.

16. The system of claim 1, wherein the drug delivery device is adapted to release the drug for a time period specified by the drug delivery signal.

17. The system of claim 1, wherein the remote device comprises a remote device controller adapted to execute an automatic algorithm to control the delivery of the electrical pulses and the drug.