Transthoracic impedance measurement in a subcutaneous device

• US 7,720,534 B2
• Filed: 09/28/2006
• Issued: 05/18/2010
• Est. Priority Date: 09/18/2000
• Status: Expired due to Fees

• Current Assignee: Cameron Health Inc (Boston Scientific Corporation)
• Original Assignee: Cameron Health Inc (Boston Scientific Corporation)
• Inventors: Bardy, Gust H., Cappato, Riccardo
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Gedeon; Brian T
• Application Number:
  US11/529,671
• Publication Number:
  US 20070021791A1
• Time in Patent Office: 1,328 Days
• Field of Search: 607/2, 607/4, 607/5, 607/119
• US Class Current: 607/2
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/29 for permanent or long-term implantation
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3906 characterised by the form of the shockwave
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Abstract

A subcutaneous implantable cardioverter-defibrillator is disclosed which has an electrically active canister which houses a source of electrical energy, a capacitor, and operational circuitry that senses the presence of potentially fatal heart rhythms. At least one subcutaneous electrode that serves as the opposite electrode from the canister is attached to the canister via a lead system. Cardioversion-defibrillation energy is delivered when the operational circuitry senses a potentially fatal heart rhythm. There are no transvenous, intracardic, or epicardial electrodes. A method of subcutaneously implanting the cardioverter-defibrillator is also disclosed as well as a kit for conducting the method.

Claims

1. A method of treating a patient comprising:

providing a cardiac stimulus system comprising a canister housing operational circuitry and a lead assembly coupled to the canister, the operational circuitry including sense circuitry for sensing patient cardiac function and delivery circuitry for delivering cardiac stimulus to the patient; and

implanting the cardiac stimulus system into a patient such that the canister and lead assembly are disposed internal to the patient with no transvenous, intracardiac, or epicardial electrodes;

wherein the cardiac stimulus system is configured to perform the following;

observing transthoracic impedance of the patient to determine whether respiration is occurring;

identifying a cardiac condition of the patient indicating need for cardiac stimulus; and

if cardiac stimulus is needed, delivering one or more electrical stimuli to the patient'"'"'s heart using at least the lead assembly.

2. The method of claim 1, wherein the cardiac stimulus system is configured such that the step of delivering one or more electrical stimuli is performed using an electrode disposed on the canister and an electrode disposed as part of the lead assembly.

3. The method of claim 2, wherein the cardiac stimulus system is configured such that the step of observing transthoracic impedance is performed by applying an electrical signal between the same electrodes that are used to apply the one or more electrical stimuli.

4. The method of claim 1, wherein the cardiac stimulus system is configured such that the step of observing transthoracic impedance is performed by applying an electrical signal between an electrode disposed on the canister and an electrode disposed as part of the lead assembly.

5. The method of claim 1, wherein the cardiac stimulus system is configured such that the one or more electrical stimuli are effective to achieve a pacing function.

6. The method of claim 1, wherein the cardiac stimulus system is configured such that the one or more electrical stimuli are effective for defibrillation.

7. The method of claim 1, wherein the step of implanting the cardiac stimulus system is performed such that the canister and lead assembly are disposed subcutaneously when the implanting step is complete.

8. The method of claim 1, wherein the step of implanting the cardiac stimulus system is performed such that the canister and lead assembly are disposed over the patient'"'"'s ribcage on the left side of the patient'"'"'s body when the implanting step is complete.

9. The method of claim 1, wherein the step of implanting the cardiac stimulus system is performed such that the canister is disposed at approximately the left inframammary crease when the implanting step is complete.

10. The method of claim 1, wherein the step of implanting the cardiac stimulus system is performed such that the canister is disposed at approximately the left axillary line of the patient when the implanting step is complete.

11. The method of claim 1, wherein the step of implanting the cardiac stimulus system is performed such that such that the canister and lead assembly are disposed subcutaneously over the patient'"'"'s ribcage on the left side of the patient'"'"'s body at approximately the left inframammary crease when the implanting step is complete.

12. The method of claim 1 further comprising using the observation of transthoracic impedance to confirm the need for cardiac stimulus before delivering one or more electrical stimuli.

13. A method of treating a patient comprising:

providing a cardiac stimulus system comprising a canister housing operational circuitry and a lead assembly coupled to the canister, the operational circuitry including sense circuitry for sensing patient cardiac function and delivery circuitry for delivering cardiac stimulus to the patient, the canister including a canister electrode and the lead assembly including a stimulus electrode coupled to the delivery circuitry for delivery of a cardiac stimulus; and

implanting the cardiac stimulus system into a patient such that the lead is nontransvenous and non-epicardial;

wherein the cardiac stimulus system is configured to perform the following;

observing a transthoracic impedance by applying a pulse between the stimulus electrode and the canister electrode;

using the transthoracic impedance to predict whether respiration is occurring; and

determining whether cardiac stimulus is needed and, if so, delivering a cardiac stimulus using the canister electrode and the stimulus electrode.

14. The method of claim 13, wherein the step of implanting the cardiac stimulus system is performed such that the canister and lead assembly are disposed subcutaneously when the implanting step is complete.

15. The method of claim 13, wherein the step of implanting the cardiac stimulus system is performed such that the canister and lead assembly are disposed over the patient'"'"'s ribcage on the left side of the patient'"'"'s body when the implanting step is complete.

16. The method of claim 13, wherein the step of implanting the cardiac stimulus system is performed such that the canister is disposed at approximately the left inframammary crease when the implanting step is complete.

17. The method of claim 13, wherein the step of implanting the cardiac stimulus system is performed such that the canister is disposed at approximately the left axillary line of the patient when the implanting step is complete.

18. The method of claim 13, wherein the step of implanting the cardiac stimulus system is performed such that the canister and lead assembly are disposed subcutaneously over the patient'"'"'s ribcage on the left side of the patient'"'"'s body at approximately the left inframammary crease when the implanting step is complete.

19. The method of claim 13 further comprising using the observation of transthoracic impedance to confirm that cardiac stimulus is needed before delivering one or more electrical stimuli.