Implant guiding programmer for implantable cardioverter defibrillator

• US 6,345,200 B1
• Filed: 02/08/2000
• Issued: 02/05/2002
• Est. Priority Date: 02/08/2000
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Adinolfi, David W., Kroll, Mark W., Mouchawar, Gabriel A.
• Primary Examiner(s): Evanisko, George R.
• Assistant Examiner(s): BIRD, JOHN M
• Application Number:
  US09/500,113
• Time in Patent Office: 728 Days
• Field of Search: 607/4, 607/5, 607/7, 607/8, 600/300, 600/301, 600/508, 128/920, 128/923, 128/924
• US Class Current: 607/8
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: Y10S 128/923 by comparison of patient data to other data

Abstract

The implant guiding programmer is configured to automatically determine the defibrillation threshold (DFT) for a particular patient and to further determine an optimal implantation configuration for an implantable cardioverter fibrillator (ICD). In one implementation, to determine the DFT for the patient, the programmer correlates patient specific data with a predictive data base containing DFT information for an entire population of patients. The patient specific data includes the age, gender, heart size, chest size and medical history of the patient. The predictive database provides information correlating patient DFT with various ranges of the patient specific data for an entire population of data. In this manner, the programmer quickly approximates the DFT for the particular patient based upon the age, gender, heart size and medical history of the patient. In another implementation, the programmer automatically determines the DFT for the patient by performing a finite element analysis on an image of the thorax of the patient generated using an MRI or a CAT scan. To this end, the programmer calculates distribution characteristics of electrical pulses generated within the thorax and determines therefrom the DFT for the patient. In either implementation, the programmer additionally determines an optimal implantation configuration for the patient, wherein the optimal configuration is one which is capable of exceeding the DFT for the patient using minimal electrical pulse energy. The optimal configuration specifies the particular make and model for the ICD, the leads, and other components, and also specifies the optimal location for implantation of the ICD and its peripheral components. The optimal configuration may also specify the defibrillation wave form. Method and apparatus embodiments of the invention are provided.

Claims

1. A method for determining an implantation configuration capable of exceeding a predetermined defibrillation threshold for an implantable cardioverter defibrillator (ICD) to be implanted into a patient, said method comprising the steps of:

accessing predictive information correlating ICD implantation configurations with corresponding defibrillation thresholds for a population of patients;

determining a particular defibrillation threshold for the patient; and

automatically determining an implantation configuration capable of providing defibrillation pulses exceeding the particular defibrillation threshold based on the particular defibrillation threshold for the patient in combination with the information correlating ICD implantation configurations with corresponding defibrillation thresholds.

2. The method of claim 1 wherein predictive information correlating ICD implantation configurations with corresponding defibrillation thresholds comprises at least one of lead type, lead position, ICD positioning, lead polarity, auxiliary wire positioning, defibrillation waveform and the amount of energy the ICD provides in a defibrillation pulse.

3. The method of claim 1 wherein an implantation configuration includes at least one implantation parameter comprising at least one of lead type, lead position, ICD type, ICD configuration, ICD positioning, lead polarity, and auxiliary wire positioning.

4. The method of claim 1 wherein the step of determining the particular defibrillation threshold for the patient includes the steps of:

accessing predictive information correlating patient clinical data with corresponding defibrillation thresholds for a population of patients;

inputting patient data for a particular patient; and

automatically determining the particular defibrillation threshold for the patient based upon the data for the patient in combination with the information correlating patient clinical data with corresponding defibrillation thresholds.

5. The method of claim 1 wherein the step of automatically determining acceptable implantation configurations also includes the step of determining an optimal implantation configuration.

6. The method of claim 5 wherein the step of determining the optimal implantation configuration includes the step of determining a configuration requiring the least amount of energy to be generated by the ICD to exceed the particular defibrillation threshold by a predetermined safety margin.

7. The method of claim 5 wherein the step of determining the optimal implantation configuration includes the step of determining a configuration providing the greatest device longevity while also capable of exceeding the particular defibrillation threshold by a predetermined safety margin.

8. The method of claim 1 wherein the step of determining the particular defibrillation threshold for the patient includes the steps of:

imaging the thorax of the patient;

modeling the thorax of the patient based upon images of the patient to generate a patient model;

specifying defibrillation electrode size, shape and position;

modeling distribution characteristics of electrical pulses in the patient based upon the patient model; and

determining the particular defibrillation threshold based on the distribution characteristics of electrical pulses in the patient and defibrillation criteria.

10. The system of claim 7 wherein the means for determining the particular defibrillation threshold for the patient includes:

means for imaging the thorax of the patient;

means for modeling the thorax of the patient based upon images of the patient to generate a patient model;

means of inputting defibrillation electrode size, shape and position;

means for modeling distribution characteristics of electrical pulses in the patient based upon the patient model; and

means for determining the particular defibrillation threshold based on the distribution characteristics of electrical pulses in the patient and a defibrillation criteria.

9. A system for determining an implantation configuration capable of exceeding a predetermined defibrillation threshold for an implantable cardioverter defibrillator (ICD) to be implanted into a patient, said system comprising:

means for storing predictive information correlating ICD implantation configurations with corresponding defibrillation thresholds for a population of patients;

means for determining a particular defibrillation threshold for the patient; and

means for automatically determining an implantation configuration capable of providing defibrillation pulses exceeding the particular defibrillation threshold based on the particular defibrillation threshold for the patient in combination with the information correlating ICD implantation configurations with corresponding defibrillation thresholds.

11. A system for determining an implantation configuration, capable of exceeding a particular defibrillation threshold for a patient, for an implantable cardioverter defibrillator (ICD) to be implanted into the patient, said system comprising:

an implantation configuration information storage unit storing predictive information correlating ICD implantation configurations with corresponding defibrillation thresholds for a population of patients;

a defibrillation threshold determination unit that determines the particular defibrllation threshold for the patient; and

an implantation configuration determination unit for automatically determining an implantation configuration capable of providing defibrillation pulses exceeding the particular defibrillation threshold based on the particular defibrillation threshold for the patient in combination with the information correlating ICD implantation configurations with corresponding defibrillation thresholds.

12. The system of claim 11 further comprising a thorax imaging unit for imaging the thorax of the patient and wherein the defibrillation threshold determination unit comprises:

a thorax modeling unit for receiving data from the thorax imaging unit and for modeling the thorax of the patient based upon images of the patient to generate a patient model;

a configuration specification unit for inputting defibrillation electrode size, shape and position;

an electrical pulse modeling unit for modeling distribution characteristics of electrical pulses in the patient based upon the patient model; and

a determination unit for determining the particular defibrillation threshold based on the distribution characteristics of electrical pulses in the patient and a defibrillation criteria.