Implantable cardioverter defibrillator with programmable capacitor charging level

• US 8,005,541 B2
• Filed: 05/11/2005
• Issued: 08/23/2011
• Est. Priority Date: 05/11/2005
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Hayes, Kenneth, Youker, Nick A., Linder, William J.
• Primary Examiner(s): Patel; Niketa I
• Assistant Examiner(s): STOKLOSA, JOSEPH A
• Application Number:
  US11/126,951
• Publication Number:
  US 20060259082A1
• Time in Patent Office: 2,295 Days
• Field of Search: 607/5, 607/7, 607/29, 607/30, 607/59
• US Class Current: 607/5
• CPC Class Codes: A61N 1/3708 for power depletion
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/3975 Power supply A61N1/378 takes precedence
• CPC Class Codes: A61N 1/3981 High voltage charging circuitry

Abstract

An implantable cardioverter defibrillator (ICD) has a programmable ICD energy level corresponding to the maximum defibrillation energy deliverable with each defibrillation shock pulse. The ICD energy level is programmable within the maximum energy capacity of the defibrillation capacitor(s) of the ICD. In various embodiments, after a user enters the ICD energy level, one or more corresponding ICD performance parameters are presented. Restrictions are applied to the energy level programming of the ICD to ensure the predictability of the one or more ICD performance parameters.

Claims

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

an implantable cardioverter defibrillator (ICD) including;

a defibrillation circuit to deliver defibrillation shock pulses each having an amount of energy programmed to a shock pulse energy level, the defibrillation circuit providing for a programmable ICD energy level being a maximum energy level up to which the shock pulse energy level is programmable; and

an energy level control module coupled to the defibrillation circuit, the energy level control module adapted to control the ICD energy level using one or more programming parameters, wherein the ICD has an energy efficiency that is increased by decreasing a difference between the ICD energy level and the shock pulse energy level; and

an external system communicatively coupled to the ICD, the external system including;

a user interface including;

a user input device adapted to receive an energy level parameter specifying the ICD energy level; and

a presentation device adapted to visually present one or more estimated ICD performance parameters each being a function of the ICD energy level;

an ICD energy level programming module coupled to the user interface, the ICD energy level programming module adapted to produce the one or more programming parameters using the received energy level parameter; and

an ICD performance estimation module coupled to the user interface, the ICD performance estimation module adapted to produce the one or more estimated ICD performance parameters using the received energy level parameter.

2. The CRM system of claim 1, wherein the ICD energy level programming module comprises a programming restriction module adapted to allow the programming of the ICD energy level according to one or more predetermined restriction rules.

3. The CRM system of claim 2, wherein the ICD performance estimation module is adapted to estimate a device longevity and a capacitor charging time being a time required to charge a defibrillation capacitor of the ICD before each of the defibrillation shock pulses is delivered, and wherein the presentation device is adapted to visually present the estimated device longevity and capacitor charging time.

4. The CRM system of claim 3, wherein the user input device is adapted to allow selection of the energy level parameter from a plurality of predetermined ICD energy level parameters.

5. The CRM system of claim 4, wherein the defibrillation circuit comprises:

a parameter receiver adapted to receive an ICD energy level parameter specifying the ICD energy level; and

an operational parameter producer coupled to the parameter receiver, the operational parameter producer adapted to produce one or more ICD operational parameters based on the ICD energy level.

6. The CRM system of claim 4, wherein the defibrillation circuit comprises a parameter receiver adapted to receive one or more ICD operational parameters controlling the ICD energy level.

7. An implantable cardioverter defibrillator (ICD), comprising:

a defibrillation circuit to deliver defibrillation shock pulses each having an amount of energy programmed to a shock pulse energy level, the defibrillation circuit including;

a defibrillation capacitor to store an energy for each of the defibrillation shock pulses; and

a capacitor charging circuit to charge the defibrillation capacitor to a maximum charging level in preparation for the delivery of each of the defibrillation shock pulses; and

an implant controller coupled to the defibrillation circuit, the implant controller including;

a parameter receiver to receive an ICD energy level parameter specifying a programmable ICD energy level controlling the maximum charging level and being a maximum value up to which the shock pulse energy level is programmable;

an operational parameter producer coupled to the parameter receiver and adapted to produce one or more ICD operational parameters including a maximum charging level and a reform charging level using the ICD energy level parameter; and

an energy level control module coupled to the operational parameter producer and adapted to control the ICD energy level, the energy level control module including;

a maximum charging level controller to control the maximum charging level of the defibrillation capacitor; and

a reform charging level controller to control the reform charging level of the defibrillation capacitor.

8. The ICD of claim 7, wherein the operational parameter producer is adapted to select the one or more ICD operational parameters from a plurality of predetermined parameter groups based on the ICD energy level parameter.

9. The ICD of claim 7, wherein the parameter receiver is adapted to receive one or more ICD operational parameters including the maximum charging level and the reform charging level.

10. The ICD of claim 7, further comprising a pacing circuit, coupled to the implant controller, to deliver pacing pulses.

11. An external system for communicating with an implantable cardioverter defibrillator (ICD), the external system comprising:

a user interface including;

a user input device adapted to receive an energy level parameter specifying an ICD energy level; and

a presentation device to visually present one or more estimated ICD performance parameters each being a function of the ICD energy level;

an ICD energy level programming module coupled to the user interface and adapted to program the ICD with the ICD energy level, the ICD energy level being a programmable maximum value up to which a shock pulse energy level is programmable, the shock pulse energy level being an amount of defibrillation energy programmed for each defibrillation shock pulse delivered from the ICD;

an ICD performance estimation module coupled to the user interface and adapted to produce the one or more estimated ICD performance parameters using the received energy level parameter.

12. The external system of claim 11, further wherein the ICD energy level programming module comprises a programming restriction module adapted to allow the programming of the ICD energy level according to one or more predetermined restriction rules.

13. The external system of claim 12, wherein the programming restriction module comprises a programming timer to time a time interval starting with an initial activation of the ICD, and wherein the programming restriction module is adapted to disallow the programming of the ICD energy level after the time interval reaches a predetermined programming time limit.

14. The external system of claim 12, wherein the programming restriction module comprises a shock pulse counter to count a number of defibrillation shock pulses delivered from the ICD since an initial activation of the ICD, and wherein the programming restriction module is adapted to disallow the programming of the ICD energy level after the number reaches a predetermined threshold number.

15. The external system of claim 12, wherein the programming restriction module comprises a programming counter to count a number of the programming of the ICD energy level performed since an initial activation of the ICD, and wherein the programming restriction module is adapted to disallow the programming of the ICD energy level after the number reaches a predetermined threshold number.

16. The external system of claim 12, wherein the programming restriction module comprises is adapted to allow the programming of the ICD energy level according to a predetermined exception to the one or more predetermined restriction rules.

17. The external system of claim 16, wherein the programming restriction module comprises an exception code receiver adapted to receive an exception code permitting the programming of the ICD energy level according to the predetermined exception to the one or more predetermined restriction rules.

18. The external system of claim 17, wherein the programming restriction module further comprises a warning message producer to produce a warning message related to one or more potential consequences of the allowing the programming of the ICD energy level according to the predetermined exception to the one or more predetermined restriction rules.

19. The external system of claim 11, wherein the ICD performance estimation module is adapted to estimate a device longevity and a capacitor charging time being a time required to charge a defibrillation capacitor of the ICD before each of the defibrillation shock pulses is delivered, and wherein the presentation device is adapted to visually present the estimated device longevity and capacitor charging time.

20. The external system of claim 11, wherein the user input device is adapted to allow selection of the energy level parameter from a plurality of predetermined ICD energy level parameters.

21. A method for operating an implantable cardioverter defibrillator (ICD), the method comprising:

receiving an energy level parameter specifying an ICD energy level from a user using an external system communicatively coupled to the ICD;

producing one or more programming parameters using the received energy level parameter, the one or more programming parameters each being a function of the ICD energy level;

producing one or more estimated ICD performance parameters using the received energy level parameter;

visually presenting the one or more estimated ICD performance parameters using the external system;

transmitting the one or more programming parameters from the external system to the ICD;

controlling the ICD energy level by the ICD using the received one or more programming parameters, the ICD energy level being a maximum defibrillation energy level up to which a shock pulse energy level is programmable, the shock pulse energy level being an amount of defibrillation energy delivered with each of defibrillation shock pulses from the ICD; and

programming the ICD with the shock pulse energy level.

22. The method of claim 21, wherein controlling the ICD energy level comprises controlling a maximum charging level of a defibrillation capacitor.

23. The method of claim 22, wherein controlling the ICD energy level further comprises controlling a reform charging level of the defibrillation capacitor.

24. The method of claim 23, wherein receiving the one or more programming parameters comprises receiving the ICD energy level parameter, and further comprising producing one or more ICD operational parameters including the maximum charging level and the reform charging level based on the ICD energy level parameter.

25. The method of claim 23, wherein receiving the one or more programming parameters comprises receiving one or more ICD operational parameters including the maximum charging level and the reform charging level.

26. The method of claim 21, further comprising:

activating the ICD using the external system;

receiving an energy level parameter;

producing the one or more programming parameters based on the energy level parameter; and

transmitting the one or more programming parameters to the ICD.

27. The method of claim 26, wherein receiving the energy level parameter comprises receiving an energy level parameter in a range of approximately 5 joules to 100 joules.

28. The method of claim 26, further comprising allowing an entry of the energy level parameter according to one or more predetermined restriction rules.

29. The method of claim 28, wherein allowing the entry of the energy level parameter comprises:

timing an interval starting with the activation of the ICD; and

disallowing the programming of the ICD energy level after the time interval reaches a predetermined programming time limit,

wherein the predetermined programming time limit is in a range of approximately 1 week to 6 months.

30. The method of claim 28, wherein allowing the entry of the energy level parameter comprises:

counting a number of defibrillation shock pulses delivered from the ICD since the activation of the ICD; and

disallowing the programming of the ICD energy level after the number reaches a predetermined threshold number,

wherein the number is in a range of approximately 3 to 15 defibrillation shock pulses.

31. The method of claim 28, wherein allowing the entry of the energy level parameter comprises:

counting a number of the programming of the ICD energy level performed since an initial activation of the ICD; and

disallowing the programming of the ICD energy level after the number reaches a predetermined threshold number,

wherein the number in a range of approximately 1 to 5 times.

32. The method of claim 28, further comprising allowing the programming of the ICD energy level according to an exception to the one or more predetermined restriction rules.

33. The method of claim 32, wherein allowing the programming of the ICD energy level according to the exception to the one or more predetermined restriction rules comprises allowing the programming of the ICD energy level after receiving a predetermined permission code.

34. The method of claim 28, wherein the one or more performance parameters comprise a device longevity of the ICD and a capacitor charging time being a time required to charge a defibrillation capacitor of the ICD before each of the defibrillation shock pulses is delivered.