Subcutaneous only implantable cardioverter-defibrillator and optional pacer

• US 7,657,311 B2
• Filed: 06/06/2006
• Issued: 02/02/2010
• Est. Priority Date: 09/18/2000
• Status: Expired due to Fees

• Current Assignee: Cameron Incorporated (Schlumberger NV)
• Original Assignee: Cameron Incorporated (Schlumberger NV)
• Inventors: Bardy, Gust H., Cappato, Riccardo
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Gedeon; Brian T
• Application Number:
  US11/447,711
• Publication Number:
  US 20060219252A1
• Time in Patent Office: 1,337 Days
• Field of Search: None
• 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 implanting a cardiac stimulus system into a patient, the system including a canister and an associated lead assembly having a proximal end for securing to the canister and a distal end including one or more lead electrodes, the method comprising:

establishing a subcutaneous pocket for receiving the canister at an inferior and lateral position relative to the patient'"'"'s atria on the left side of the patient'"'"'s torso and over the patient'"'"'s ribs;

inserting the canister into the subcutaneous pocket;

establishing a subcutaneous path for receiving the lead assembly extending over one or more of the patient'"'"'s ribs at least partly towards the patient'"'"'s sternum;

inserting at least a distal portion of the lead assembly into the subcutaneous path;

wherein the step of inserting the canister is performed such that the canister is placed in the left posterior axillary line approximately lateral to the tip of the inferior portion of the scapula of the patient; and

wherein the subcutaneous path terminates in a subcutaneous and precordial position on the chest of the patient such that the lead assembly, once inserted, comprises no transvenous, intracardiac, or epicardial electrodes.

2. The method of claim 1, further comprising leaving the patient'"'"'s ribcage intact throughout the procedure.

3. The method of claim 1, further comprising leaving the patient'"'"'s pericardium intact throughout the procedure.

4. The method of claim 1, further comprising finishing the procedure without transvenously accessing the patient'"'"'s heart.

5. The method of claim 4, wherein the step of finishing the procedure includes activating the cardiac stimulus system.

6. The method of claim 5, wherein the step of finishing the procedure includes configuring the cardiac stimulus system to monitor cardiac function and deliver electrical cardiac therapy when indicated by an apparent abnormal cardiac condition.

7. The method of claim 6, wherein the step of configuring the cardiac stimulus system to monitor cardiac function includes selecting a sensing vector defined between a first electrode on the lead assembly and a first electrode disposed on or integrated into the canister, and the step of configuring the cardiac stimulus system to deliver electrical cardiac therapy includes selecting a therapy vector defined between the same electrodes that define the sensing vector.

8. The method of claim 6, wherein the step of configuring the cardiac stimulus system to monitor cardiac function includes selecting a sensing vector using a first electrode on the lead assembly, and the step of configuring the cardiac stimulus system to deliver electrical cardiac therapy includes selecting a therapy vector using a second electrode on the lead assembly.

9. The method of claim 6, wherein the step of configuring the cardiac stimulus system to deliver electrical cardiac therapy includes selecting a therapy vector including a first electrode and a second electrode, and the first electrode is part of the lead assembly and the second electrode is disposed on or integrated into the canister.

10. The method of claim 1 wherein the subcutaneous pocket is at approximately the level of the 5^th rib.

11. A method of implanting a cardiac stimulus system into a patient, the system including means for housing operational circuitry that powers and controls the cardiac stimulus system and an associated lead assembly having a proximal end for securing to the housing means and a distal end including one or more lead electrodes, the method comprising:

establishing a subcutaneous pocket for receiving the means for housing at an inferior and lateral position relative to the patient'"'"'s atria on the left side of the patient'"'"'s torso and over the patient'"'"'s ribs;

inserting the housing means into the subcutaneous pocket;

establishing a subcutaneous path for receiving the lead assembly extending over one or more of the patient'"'"'s ribs at least partly towards the patient'"'"'s sternum;

inserting at least a distal portion of the lead assembly into the subcutaneous path;

wherein the step of inserting the canister is performed such that the canister is placed in the left posterior axillary line approximately lateral to the tip of the inferior portion of the scapula of the patient; and

wherein the subcutaneous path terminates in a subcutaneous and precordial position on the chest of the patient such that the lead assembly, once inserted, comprises no transvenous, intracardiac, or epicardial electrodes.

12. The method of claim 11, further comprising leaving the patient'"'"'s ribcage intact throughout the procedure.

13. The method of claim 11, further comprising leaving the patient'"'"'s pericardium intact throughout the procedure.

14. The method of claim 11, further comprising finishing the procedure without transvenously accessing the patient'"'"'s heart.

15. The method of claim 14, wherein the step of finishing the procedure includes activating the cardiac stimulus system.

16. The method of claim 15, wherein the step of finishing the procedure includes configuring the cardiac stimulus system to monitor cardiac function and deliver electrical cardiac therapy when indicated by an apparent abnormal cardiac function.

17. The method of claim 16, wherein the step of configuring the cardiac stimulus system to monitor cardiac function includes selecting a sensing vector defined between a first electrode disposed on the lead assembly and a first electrode disposed on or integrated into the housing means, and the step of configuring the cardiac stimulus system to deliver electrical cardiac therapy includes selecting a therapy vector defined between the same electrodes that define the sensing vector.

18. The method of claim 16, wherein the step of configuring the cardiac stimulus system to monitor cardiac function includes selecting a sensing vector using a first electrode disposed on the lead assembly, and the step of configuring the cardiac stimulus system to deliver electrical cardiac therapy includes selecting a therapy vector using a second electrode disposed on the lead assembly.

19. The method of claim 16, wherein the step of configuring the cardiac stimulus system to deliver electrical cardiac therapy includes selecting a therapy vector including a first electrode and a second electrode, and the first electrode is secured to the lead assembly and the second electrode is disposed on or integrated into the housing means.

20. The method of claim 11 wherein the subcutaneous pocket is at approximately the level of the 5^th rib.

21. A method of implanting a cardiac stimulus system into a patient, the system including a canister and an associated lead assembly having a proximal end adapted for securing to the canister and a distal end including one or more lead electrodes, the method comprising:

establishing a subcutaneous pocket for receiving the canister at an inferior and lateral position relative to the patient'"'"'s atria on the left side of the patient'"'"'s torso and over the patient'"'"'s ribs;

inserting the canister into the subcutaneous pocket;

establishing a subcutaneous path for receiving the lead assembly extending over one or more of the patient'"'"'s ribs at least partly towards the patient'"'"'s sternum;

inserting at least a distal portion of the lead assembly into the subcutaneous path;

activating the cardiac stimulus system;

wherein the activated cardiac stimulus system is configured to deliver therapy using a vector defined between a first electrode and a second electrode, wherein the first electrode is disposed on the canister and the second electrode is disposed on or integrated into the lead assembly;

wherein the step of inserting the canister is performed such that the canister is placed in the left posterior axillary line approximately lateral to the tip of the inferior portion of the scapula of the patient; and

wherein the subcutaneous path terminates in a subcutaneous and precordial position on the chest of the patient such that the lead assembly, once inserted, comprises no transvenous, intracardiac, or epicardial electrodes.

22. The method of claim 21, wherein the step of activating the cardiac stimulus system includes selecting an energy level for therapy delivery, the energy level being in the range of 40-150 Joules.

23. The method of claim 21 wherein the subcutaneous pocket is at approximately the level of the 5^th rib.